AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL TUBINGEN

Replacement, Ossicular Prosthesis, Total

HEINZ KURZ GMBH MEDIZINTECHNIK

The following data is part of a premarket notification filed by Heinz Kurz Gmbh Medizintechnik with the FDA for Aerial Prosthesis, Aerial Prosthesis, Model Dusseldorf, Dresden Aerial Prosthesis, Aerial Prosthesis, Model Tubingen.

Pre-market Notification Details

Device IDK972585
510k NumberK972585
Device Name:AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL TUBINGEN
ClassificationReplacement, Ossicular Prosthesis, Total
Applicant HEINZ KURZ GMBH MEDIZINTECHNIK TUBINGER STRASSE 3 Dusslingen,  DE D-72144
ContactDagmar S Maser
CorrespondentDagmar S Maser
HEINZ KURZ GMBH MEDIZINTECHNIK TUBINGER STRASSE 3 Dusslingen,  DE D-72144
Product CodeETA  
CFR Regulation Number874.3495 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-07-10
Decision Date1997-08-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
EHKM10040341 K972585 000
EHKM10040491 K972585 000
EHKM10042341 K972585 000
EHKM10042351 K972585 000
EHKM10042361 K972585 000
EHKM10042371 K972585 000
EHKM10042381 K972585 000
EHKM10042391 K972585 000
EHKM10042401 K972585 000
EHKM10042411 K972585 000
EHKM10040481 K972585 000
EHKM10040461 K972585 000
EHKM10040441 K972585 000
EHKM10040351 K972585 000
EHKM10040361 K972585 000
EHKM10040371 K972585 000
EHKM10040381 K972585 000
EHKM10040391 K972585 000
EHKM10040401 K972585 000
EHKM10040411 K972585 000
EHKM10040421 K972585 000
EHKM10040431 K972585 000
EHKM10042421 K972585 000
EHKM10042431 K972585 000
EHKM10042441 K972585 000
EHKM10044431 K972585 000
EHKM10044441 K972585 000
EHKM10044461 K972585 000
EHKM10044481 K972585 000
EHKM10044491 K972585 000
EHKM10044581 K972585 000
EHKM10044591 K972585 000
EHKM10044601 K972585 000
EHKM10044611 K972585 000
EHKM10044421 K972585 000
EHKM10044411 K972585 000
EHKM10044401 K972585 000
EHKM10042461 K972585 000
EHKM10042481 K972585 000
EHKM10042491 K972585 000
EHKM10044341 K972585 000
EHKM10044351 K972585 000
EHKM10044361 K972585 000
EHKM10044371 K972585 000
EHKM10044381 K972585 000
EHKM10044391 K972585 000
EHKM10044621 K972585 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.