Cellusheet, Cellufil

Dressing, Wound, Collagen

Human Biosciences, Inc.

The following data is part of a premarket notification filed by Human Biosciences, Inc. with the FDA for Cellusheet, Cellufil.

Pre-market Notification Details

Device IDK213092
510k NumberK213092
Device Name:Cellusheet, Cellufil
ClassificationDressing, Wound, Collagen
Applicant Human Biosciences, Inc. 940 Clopper Rd. Gaithersburg,  MD  20878
ContactJigar Patel
CorrespondentJack Slovick
Methodize P.O. Box 463 Nevis,  MN  56467
Product CodeKGN  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductYes
Date Received2021-09-24
Decision Date2021-12-15

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