GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05

Control, Plasma, Abnormal

GRADIPORE LTD.

The following data is part of a premarket notification filed by Gradipore Ltd. with the FDA for Gradiplasma La High, Gradiplasma La Low Models Lahp-1, Lahp-05, Lalp-1, Lalp-05.

Pre-market Notification Details

Device IDK993332
510k NumberK993332
Device Name:GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05
ClassificationControl, Plasma, Abnormal
Applicant GRADIPORE LTD. LOT16 RIVERSIDE CORPORATE PARK 35-105 DELHI ROAD North Ryde,  AU Nsw 2113
ContactRhonda Pilgrim
CorrespondentRhonda Pilgrim
GRADIPORE LTD. LOT16 RIVERSIDE CORPORATE PARK 35-105 DELHI ROAD North Ryde,  AU Nsw 2113
Product CodeGGC  
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-10-04
Decision Date2000-02-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414023519 K993332 000
00630414023502 K993332 000
00842768008368 K993332 000
00842768008351 K993332 000
00842768019685 K993332 000
00842768019678 K993332 000

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