The following data is part of a premarket notification filed by Barrier Concepts, Inc. with the FDA for Clothinguard.
| Device ID | K894760 |
| 510k Number | K894760 |
| Device Name: | CLOTHINGUARD |
| Classification | Dress, Surgical |
| Applicant | BARRIER CONCEPTS, INC. POST OFFICE BOX 11421 Columbia, SC 29211 |
| Contact | Steven C Hasterok |
| Correspondent | Steven C Hasterok BARRIER CONCEPTS, INC. POST OFFICE BOX 11421 Columbia, SC 29211 |
| Product Code | FYE |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-27 |
| Decision Date | 1989-08-18 |