The following data is part of a premarket notification filed by Graham-field, Inc. with the FDA for Unna Boot Dressing W/calamine.
| Device ID | K883224 |
| 510k Number | K883224 |
| Device Name: | UNNA BOOT DRESSING W/CALAMINE |
| Classification | Dressing, Wound, Drug |
| Applicant | GRAHAM-FIELD, INC. 400 RABRO DR. EAST Hauppauge, NY 11788 |
| Contact | Terry O'hara |
| Correspondent | Terry O'hara GRAHAM-FIELD, INC. 400 RABRO DR. EAST Hauppauge, NY 11788 |
| 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 | 1988-07-29 |
| Decision Date | 1989-01-05 |