The following data is part of a premarket notification filed by Steridyne Laboratories, Inc. with the FDA for Pad, Petrolatum & Bismuth Tribromophenate Impreg..
| Device ID | K870430 |
| 510k Number | K870430 |
| Device Name: | PAD, PETROLATUM & BISMUTH TRIBROMOPHENATE IMPREG. |
| Classification | Dressing, Wound, Drug |
| 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 | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-03 |
| Decision Date | 1987-04-13 |