The following data is part of a premarket notification filed by Covalon Technologies, Inc. with the FDA for Surgiclear Antimicrobial Clear Silicone Adhesive Dressing With Chlorhexidine And Silver.
| Device ID | K121819 |
| 510k Number | K121819 |
| Device Name: | SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER |
| Classification | Dressing, Wound, Drug |
| Applicant | COVALON TECHNOLOGIES, INC. 405 BRITANNIA RD. EAST SUITE 106 Mississauga, Ontario, CA L4z 3e6 |
| Contact | Christopher Fredric |
| Correspondent | Christopher Fredric COVALON TECHNOLOGIES, INC. 405 BRITANNIA RD. EAST SUITE 106 Mississauga, Ontario, CA L4z 3e6 |
| 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 | 2012-06-21 |
| Decision Date | 2012-08-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00825439010419 | K121819 | 000 |
| 00825439010402 | K121819 | 000 |
| 00825439010396 | K121819 | 000 |
| 00825439010341 | K121819 | 000 |
| 00825439010303 | K121819 | 000 |
| 00825439010280 | K121819 | 000 |
| 00825439010266 | K121819 | 000 |