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 |