The following data is part of a premarket notification filed by The Kendall Company, L.p. with the FDA for Kerlix Md Antimicrobial Gauze Dressing.
| Device ID | K990530 |
| 510k Number | K990530 |
| Device Name: | KERLIX MD ANTIMICROBIAL GAUZE DRESSING |
| Classification | Dressing, Wound, Occlusive |
| Applicant | THE KENDALL COMPANY, L.P. 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | David A Olson |
| Correspondent | David A Olson THE KENDALL COMPANY, L.P. 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | NAD |
| CFR Regulation Number | 878.4020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-19 |
| Decision Date | 2000-01-31 |
| Summary: | summary |