The following data is part of a premarket notification filed by Icn Pharmaceuticals, Inc. with the FDA for Suan Flat Dissector Sponges.
| Device ID | K914082 |
| 510k Number | K914082 |
| Device Name: | SUAN FLAT DISSECTOR SPONGES |
| Classification | Gauze/sponge, Internal, X-ray Detectable |
| Applicant | ICN PHARMACEUTICALS, INC. ICN PLAZA 3300 HYLAND AVENUE Costa Mesa, CA 92626 |
| Contact | Stephen J Goldner |
| Correspondent | Stephen J Goldner ICN PHARMACEUTICALS, INC. ICN PLAZA 3300 HYLAND AVENUE Costa Mesa, CA 92626 |
| Product Code | GDY |
| CFR Regulation Number | 878.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-11 |
| Decision Date | 1991-11-27 |