The following data is part of a premarket notification filed by Medline with the FDA for Medline, Gore-tex Barrier, Surgical Gowns & Drapes.
| Device ID | K915502 |
| 510k Number | K915502 |
| Device Name: | MEDLINE, GORE-TEX BARRIER, SURGICAL GOWNS & DRAPES |
| Classification | Gown, Surgical |
| Applicant | MEDLINE ONE MEDLINE PLACE Mundlelein, IL 60060 |
| Contact | Lock |
| Correspondent | Lock MEDLINE ONE MEDLINE PLACE Mundlelein, IL 60060 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-09 |
| Decision Date | 1992-04-29 |