The following data is part of a premarket notification filed by Border Opportunity Saver Systems, Inc. with the FDA for Sterile Disposable Surgical Gown W/ Towel.
| Device ID | K920568 |
| 510k Number | K920568 |
| Device Name: | STERILE DISPOSABLE SURGICAL GOWN W/ TOWEL |
| Classification | Gown, Surgical |
| Applicant | BORDER OPPORTUNITY SAVER SYSTEMS, INC. 56 WESTCOTT RD. Stamford, CT 06902 |
| Contact | Cornelia Damsky |
| Correspondent | Cornelia Damsky BORDER OPPORTUNITY SAVER SYSTEMS, INC. 56 WESTCOTT RD. Stamford, CT 06902 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-07 |
| Decision Date | 1992-10-22 |