The following data is part of a premarket notification filed by Medical Sterilization, Inc. with the FDA for Sterile Back Surgical Gown With Hand Towel.
| Device ID | K984422 |
| 510k Number | K984422 |
| Device Name: | STERILE BACK SURGICAL GOWN WITH HAND TOWEL |
| Classification | Gown, Surgical |
| Applicant | MEDICAL STERILIZATION, INC. 225 UNDERHILL BLVD. Syosset, NY 11791 |
| Contact | David Morganstern |
| Correspondent | David Morganstern 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 | 1998-12-10 |
| Decision Date | 1999-04-02 |