The following data is part of a premarket notification filed by Dermacare with the FDA for Dermacare Tie Holder.
Device ID | K893995 |
510k Number | K893995 |
Device Name: | DERMACARE TIE HOLDER |
Classification | Retention Device, Suture |
Applicant | DERMACARE 7651 NATIONAL TURNPIKE Louisville, KY 40214 |
Contact | Ryan Sell |
Correspondent | Ryan Sell DERMACARE 7651 NATIONAL TURNPIKE Louisville, KY 40214 |
Product Code | KGS |
CFR Regulation Number | 878.4930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-06-05 |
Decision Date | 1989-08-11 |