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.
Device ID | K140389 |
510k Number | K140389 |
Device Name: | CHLORADERM ANTIMICROBIAL TRANSPARENT THIN FILM DRESSING, 2 3/8 X 2 3/4, 4 X 4 3/4 |
Classification | Dressing, Wound, Drug |
Applicant | ENTROTECH LIFE SCIENCES INC. 755 N. MATHILDA AVE., STE 100 Sunnyvale, CA 94085 |
Contact | Valerie Defiesta-ng |
Correspondent | Valerie Defiesta-ng ENTROTECH LIFE SCIENCES INC. 755 N. MATHILDA AVE., STE 100 Sunnyvale, CA 94085 |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2014-02-14 |
Decision Date | 2014-11-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
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 |