The following data is part of a premarket notification filed by Covalon Technologies, Inc. with the FDA for Iv Clear Antimicrobial Clear Silicone Adhesive Dressing With Chlorhexidine And Silver.
| Device ID | K112549 |
| 510k Number | K112549 |
| Device Name: | IV CLEAR 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 | Kim Crooks |
| Correspondent | Kim Crooks 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 | 2011-09-01 |
| Decision Date | 2012-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00825439016626 | K112549 | 000 |
| 00825439010488 | K112549 | 000 |
| 00825439010372 | K112549 | 000 |
| 00825439010389 | K112549 | 000 |
| 00825439010181 | K112549 | 000 |
| 00825439010167 | K112549 | 000 |
| 00825439010143 | K112549 | 000 |