The following data is part of a premarket notification filed by Convertors with the FDA for Surgical Gowns, Sheets.
| Device ID | K781959 |
| 510k Number | K781959 |
| Device Name: | SURGICAL GOWNS, SHEETS |
| Classification | Drape, Surgical |
| Applicant | CONVERTORS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-11-21 |
| Decision Date | 1979-01-10 |