The following data is part of a premarket notification filed by Dms Miami, Inc. with the FDA for Magna Surgeons Gowns.
| Device ID | K911508 |
| 510k Number | K911508 |
| Device Name: | MAGNA SURGEONS GOWNS |
| Classification | Gown, Surgical |
| Applicant | DMS MIAMI, INC. P.O. BOX 4217 VEGA BAJA, PUERTO RICO 00764 Vega Baja, GW |
| Contact | Jesse H Gonzalez |
| Correspondent | Jesse H Gonzalez DMS MIAMI, INC. P.O. BOX 4217 VEGA BAJA, PUERTO RICO 00764 Vega Baja, GW |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-03 |
| Decision Date | 1991-06-17 |