The following data is part of a premarket notification filed by Medgroup Enterprises, Inc. with the FDA for Medgroup Enterprises Cotton Gauze Sponges-non Ster.
| Device ID | K871464 |
| 510k Number | K871464 |
| Device Name: | MEDGROUP ENTERPRISES COTTON GAUZE SPONGES-NON STER |
| Classification | Cotton, Roll |
| Applicant | MEDGROUP ENTERPRISES, INC. 1201 SOUTH FLOWER ST. Burbank, CA 91502 |
| Contact | Raymond D Clark |
| Correspondent | Raymond D Clark MEDGROUP ENTERPRISES, INC. 1201 SOUTH FLOWER ST. Burbank, CA 91502 |
| Product Code | EFN |
| CFR Regulation Number | 872.6050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-14 |
| Decision Date | 1987-04-30 |