The following data is part of a premarket notification filed by Acumed, Inc. with the FDA for Acumed Carpal Tunnel Release Kit.
| Device ID | K933638 |
| 510k Number | K933638 |
| Device Name: | ACUMED CARPAL TUNNEL RELEASE KIT |
| Classification | Arthroscope |
| Applicant | ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
| Contact | Gene Conrad |
| Correspondent | Gene Conrad ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-27 |
| Decision Date | 1994-03-24 |