The following data is part of a premarket notification filed by Kells Medical, Inc. with the FDA for Dermidress.
| Device ID | K844463 |
| 510k Number | K844463 |
| Device Name: | DERMIDRESS |
| Classification | Tape And Bandage, Adhesive |
| Applicant | KELLS MEDICAL, INC. 136 SHORE DR. Burr Ridge, IL 60521 |
| Contact | John P Sweeney |
| Correspondent | John P Sweeney KELLS MEDICAL, INC. 136 SHORE DR. Burr Ridge, IL 60521 |
| Product Code | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-20 |
| Decision Date | 1985-01-08 |