The following data is part of a premarket notification filed by Simpex, Inc. with the FDA for Simpex Inc. Surgical Dressing.
| Device ID | K913794 |
| 510k Number | K913794 |
| Device Name: | SIMPEX INC. SURGICAL DRESSING |
| Classification | Gauze/sponge, Internal, X-ray Detectable |
| Applicant | SIMPEX, INC. 801 OLD YORK RD. SUITE 318 Jenkintown, PA 19046 |
| Contact | Xi Mei |
| Correspondent | Xi Mei SIMPEX, INC. 801 OLD YORK RD. SUITE 318 Jenkintown, PA 19046 |
| Product Code | GDY |
| CFR Regulation Number | 878.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-23 |
| Decision Date | 1991-11-20 |