The following data is part of a premarket notification filed by Clinitech, Inc. with the FDA for Sterile Surgical Gown.
| Device ID | K895667 |
| 510k Number | K895667 |
| Device Name: | STERILE SURGICAL GOWN |
| Classification | Dress, Surgical |
| Applicant | CLINITECH, INC. P.O. BOX 16598 Ft. Worth, TX 76162 |
| Contact | Louie F Turner |
| Correspondent | Louie F Turner CLINITECH, INC. P.O. BOX 16598 Ft. Worth, TX 76162 |
| Product Code | FYE |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-20 |
| Decision Date | 1989-10-13 |