The following data is part of a premarket notification filed by Tek-aid, Inc. with the FDA for Le Veen Wound Splint.
| Device ID | K863570 |
| 510k Number | K863570 |
| Device Name: | LE VEEN WOUND SPLINT |
| Classification | Retention Device, Suture |
| Applicant | TEK-AID, INC. 1023 WAPPOO ROAD, SUITE 41-B Charleston, SC 29407 |
| Contact | Susan J Smoak |
| Correspondent | Susan J Smoak TEK-AID, INC. 1023 WAPPOO ROAD, SUITE 41-B Charleston, SC 29407 |
| Product Code | KGS |
| CFR Regulation Number | 878.4930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-12 |
| Decision Date | 1986-09-29 |