The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Acufex Shoulder Holder.
| Device ID | K841388 |
| 510k Number | K841388 |
| Device Name: | ACUFEX SHOULDER HOLDER |
| Classification | Apparatus, Traction, Non-powered |
| Applicant | ACUFEX MICROSURGICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HST |
| CFR Regulation Number | 888.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-03 |
| Decision Date | 1984-05-16 |