The following data is part of a premarket notification filed by Dav-mar Medical Products, Inc. with the FDA for Gauze Sponges.
| Device ID | K924650 |
| 510k Number | K924650 |
| Device Name: | GAUZE SPONGES |
| Classification | Gauze, External (with Drug/biologic/animal Source Material) |
| Applicant | DAV-MAR MEDICAL PRODUCTS, INC. 66-2 HARNED RD. Commack, NY 11725 |
| Contact | Steven Lhersch |
| Correspondent | Steven Lhersch DAV-MAR MEDICAL PRODUCTS, INC. 66-2 HARNED RD. Commack, NY 11725 |
| Product Code | GER |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-15 |
| Decision Date | 1993-01-11 |