COLLATEK HYDROGEL

Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic

BIOCORE MEDICAL TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Biocore Medical Technologies, Inc. with the FDA for Collatek Hydrogel.

Pre-market Notification Details

Device IDK022995
510k NumberK022995
Device Name:COLLATEK HYDROGEL
ClassificationDressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Applicant BIOCORE MEDICAL TECHNOLOGIES, INC. 11800 TECH ROAD, SUITE # 240 Silver Spring,  MD  20904 -1908
ContactAjay Kumar
CorrespondentAjay Kumar
BIOCORE MEDICAL TECHNOLOGIES, INC. 11800 TECH ROAD, SUITE # 240 Silver Spring,  MD  20904 -1908
Product CodeMGQ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-09-09
Decision Date2002-12-02
Summary:summary

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