The following data is part of a premarket notification filed by Derma-lock Medical Corp. with the FDA for Epi-lock T.m. Primaderm.
| Device ID | K874291 |
| 510k Number | K874291 |
| Device Name: | EPI-LOCK T.M. PRIMADERM |
| Classification | Dressing, Wound, Drug |
| Applicant | DERMA-LOCK MEDICAL CORP. 8200 S. AKRON STREET, STE. 108 P.O. BOX 4785 Englewood, CO 80155 |
| Contact | Michael D Riddle |
| Correspondent | Michael D Riddle DERMA-LOCK MEDICAL CORP. 8200 S. AKRON STREET, STE. 108 P.O. BOX 4785 Englewood, CO 80155 |
| 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 | 1987-10-20 |
| Decision Date | 1987-11-10 |