The following data is part of a premarket notification filed by Kells Medical, Inc. with the FDA for Dermistrip.
| Device ID | K861972 |
| 510k Number | K861972 |
| Device Name: | DERMISTRIP |
| Classification | Dressing, Wound, Drug |
| Applicant | KELLS MEDICAL, INC. 136 SHORE DR. Burr Ridge, IL 60521 |
| Contact | John Sweeney |
| Correspondent | John Sweeney KELLS MEDICAL, INC. 136 SHORE DR. Burr Ridge, IL 60521 |
| 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 | 1986-05-21 |
| Decision Date | 1986-06-27 |