The following data is part of a premarket notification filed by Medtech Intl., Inc. with the FDA for Gauze & Cotton Sponges.
| Device ID | K790389 |
| 510k Number | K790389 |
| Device Name: | GAUZE & COTTON SPONGES |
| Classification | Gauze/sponge, Internal, X-ray Detectable |
| Applicant | MEDTECH INTL., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GDY |
| CFR Regulation Number | 878.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-02-26 |
| Decision Date | 1979-03-26 |