The following data is part of a premarket notification filed by Protect Corp. Of Indiana, Inc. with the FDA for Various Disposable Surgical Garments.
| Device ID | K895235 |
| 510k Number | K895235 |
| Device Name: | VARIOUS DISPOSABLE SURGICAL GARMENTS |
| Classification | Dress, Surgical |
| Applicant | PROTECT CORP. OF INDIANA, INC. 3717 NORTH RURAL Indianapolis, IN 46218 |
| Contact | Richard H Graves |
| Correspondent | Richard H Graves PROTECT CORP. OF INDIANA, INC. 3717 NORTH RURAL Indianapolis, IN 46218 |
| Product Code | FYE |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-07 |
| Decision Date | 1989-09-19 |