The following data is part of a premarket notification filed by Tyco Healthcare with the FDA for Kendall Kerlix Antimicrobial Super Sponge Dressing For Otc Use, Model 6662.
| Device ID | K070653 |
| 510k Number | K070653 |
| Device Name: | KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662 |
| Classification | Dressing, Wound, Drug |
| Applicant | TYCO HEALTHCARE 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | Paul W Evans |
| Correspondent | Paul W Evans TYCO HEALTHCARE 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| 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 | 2007-03-09 |
| Decision Date | 2007-09-12 |
| Summary: | summary |