The following data is part of a premarket notification filed by Medical Sterilization, Inc. with the FDA for Msi Sterile Back Surgical Gown Pack Hand Towel.
| Device ID | K912803 |
| 510k Number | K912803 |
| Device Name: | MSI STERILE BACK SURGICAL GOWN PACK HAND TOWEL |
| Classification | Gown, Surgical |
| Applicant | MEDICAL STERILIZATION, INC. 225 UNDERHILL BLVD. Syosset, NY 11791 |
| Contact | Michael G.fogarty |
| Correspondent | Michael G.fogarty MEDICAL STERILIZATION, INC. 225 UNDERHILL BLVD. Syosset, NY 11791 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-25 |
| Decision Date | 1992-01-10 |