CHLORADERM ANTIMICROBIAL TRANSPARENT THIN FILM DRESSING, 2 3/8 X 2 3/4, 4 X 4 3/4

Dressing, Wound, Drug

ENTROTECH LIFE SCIENCES INC.

The following data is part of a premarket notification filed by Entrotech Life Sciences Inc. with the FDA for Chloraderm Antimicrobial Transparent Thin Film Dressing, 2 3/8 X 2 3/4, 4 X 4 3/4.

Pre-market Notification Details

Device IDK140389
510k NumberK140389
Device Name:CHLORADERM ANTIMICROBIAL TRANSPARENT THIN FILM DRESSING, 2 3/8 X 2 3/4, 4 X 4 3/4
ClassificationDressing, Wound, Drug
Applicant ENTROTECH LIFE SCIENCES INC. 755 N. MATHILDA AVE., STE 100 Sunnyvale,  CA  94085
ContactValerie Defiesta-ng
CorrespondentValerie Defiesta-ng
ENTROTECH LIFE SCIENCES INC. 755 N. MATHILDA AVE., STE 100 Sunnyvale,  CA  94085
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2014-02-14
Decision Date2014-11-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B5591488CH00 K140389 000
B5591492CASE3 K140389 000
B5591483BOX1 K140389 000
B5591483CH00 K140389 000
B5591484BOX1 K140389 000
B5591484CH00 K140389 000
B5591485BOX1 K140389 000
B5591485CH00 K140389 000
B5591488BOX1 K140389 000
B5591491CH0 K140389 000

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