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 |