The following data is part of a premarket notification filed by Patient Safety Products, Inc. with the FDA for Sterile Barrier Sleeve And Cover.
| Device ID | K930552 |
| 510k Number | K930552 |
| Device Name: | STERILE BARRIER SLEEVE AND COVER |
| Classification | Cover, Barrier, Protective |
| Applicant | PATIENT SAFETY PRODUCTS, INC. 1185 DEAN ST. Brooklyn, NY 11216 |
| Contact | Edmund Burton |
| Correspondent | Edmund Burton PATIENT SAFETY PRODUCTS, INC. 1185 DEAN ST. Brooklyn, NY 11216 |
| Product Code | MMP |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-03 |
| Decision Date | 1994-07-05 |