The following data is part of a premarket notification filed by Cohort Medical Products Group, Inc. with the FDA for Cohort Discectomy Systems (cds).
| Device ID | K964975 |
| 510k Number | K964975 |
| Device Name: | COHORT DISCECTOMY SYSTEMS (CDS) |
| Classification | Arthroscope |
| Applicant | COHORT MEDICAL PRODUCTS GROUP, INC. 3583 INVESTMENT BLVD., #5 Hayward, CA 94545 |
| Contact | Ronald C Allen |
| Correspondent | Ronald C Allen COHORT MEDICAL PRODUCTS GROUP, INC. 3583 INVESTMENT BLVD., #5 Hayward, CA 94545 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-12 |
| Decision Date | 1997-02-24 |