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 |