The following data is part of a premarket notification filed by Cedars Medical Center with the FDA for Dexter Hand Evaluation And Therapy System.
| Device ID | K915144 |
| 510k Number | K915144 |
| Device Name: | DEXTER HAND EVALUATION AND THERAPY SYSTEM |
| Classification | System, Isokinetic Testing And Evaluation |
| Applicant | CEDARS MEDICAL CENTER 1205 DRAKE DR. SUITE E P.O. BOX 2100 Davis, CA 95616 |
| Contact | Karen Comisso-bond |
| Correspondent | Karen Comisso-bond CEDARS MEDICAL CENTER 1205 DRAKE DR. SUITE E P.O. BOX 2100 Davis, CA 95616 |
| Product Code | IKK |
| CFR Regulation Number | 890.1925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-14 |
| Decision Date | 1992-04-02 |