The following data is part of a premarket notification filed by Surgical Specialties, Inc. with the FDA for S1 Vaginal Packing.
| Device ID | K861443 |
| 510k Number | K861443 |
| Device Name: | S1 VAGINAL PACKING |
| Classification | Gauze/sponge, Internal |
| Applicant | SURGICAL SPECIALTIES, INC. P.O. BOX 310 Reading, PA 19607 |
| Contact | George Erl |
| Correspondent | George Erl SURGICAL SPECIALTIES, INC. P.O. BOX 310 Reading, PA 19607 |
| Product Code | EFQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-17 |
| Decision Date | 1986-05-06 |