BIOTEQUE SCALP VEIN SET

Set, Administration, Intravascular

BIOTEQUE CORP.

The following data is part of a premarket notification filed by Bioteque Corp. with the FDA for Bioteque Scalp Vein Set.

Pre-market Notification Details

Device IDK012526
510k NumberK012526
Device Name:BIOTEQUE SCALP VEIN SET
ClassificationSet, Administration, Intravascular
Applicant BIOTEQUE CORP. 900 N. SWITZER CANYON DR. #142 Flagstaff,  AZ  86001
ContactAllen Reich
CorrespondentAllen Reich
BIOTEQUE CORP. 900 N. SWITZER CANYON DR. #142 Flagstaff,  AZ  86001
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-08-06
Decision Date2001-09-14
Summary:summary

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