The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Silver Antimicrobial Wound Gauze (sponge).
| Device ID | K042164 |
| 510k Number | K042164 |
| Device Name: | SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE) |
| Classification | Dressing, Wound, Drug |
| Applicant | MEDLINE INDUSTRIES, INC. 12232 SW GARDEN PL. Portland, OR |
| Contact | Bruce Gibbins |
| Correspondent | Bruce Gibbins MEDLINE INDUSTRIES, INC. 12232 SW GARDEN PL. Portland, OR |
| 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 | 2004-08-11 |
| Decision Date | 2005-06-09 |
| Summary: | summary |