The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Acufex Universal Leg Holder.
| Device ID | K830707 |
| 510k Number | K830707 |
| Device Name: | ACUFEX UNIVERSAL LEG HOLDER |
| Classification | Operating Room Accessories Table Tray |
| Applicant | ACUFEX MICROSURGICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FWZ |
| CFR Regulation Number | 878.4950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-07 |
| Decision Date | 1983-05-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556605691 | K830707 | 000 |
| 03596010388926 | K830707 | 000 |
| 03596010451897 | K830707 | 000 |