The following data is part of a premarket notification filed by Steridyne Laboratories, Inc. with the FDA for Gauze, Absorbent, Iodoform Impregnated.
| Device ID | K870431 |
| 510k Number | K870431 |
| Device Name: | GAUZE, ABSORBENT, IODOFORM IMPREGNATED |
| Classification | Gauze/sponge, Internal, With Drug/biologic, Animal Source Material |
| Applicant | STERIDYNE LABORATORIES, INC. WASHINGTON SQUARE 1050 CONNECTICUT AVENUE, N.W. Washington, DC 20036 |
| Contact | Peter S Reichertz |
| Correspondent | Peter S Reichertz STERIDYNE LABORATORIES, INC. WASHINGTON SQUARE 1050 CONNECTICUT AVENUE, N.W. Washington, DC 20036 |
| Product Code | GEL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-03 |
| Decision Date | 1987-02-26 |