The following data is part of a premarket notification filed by Coherent Medical Group with the FDA for Model 5001 Micromanipulator For Use W/tf-25 Co2.
| Device ID | K873246 |
| 510k Number | K873246 |
| Device Name: | MODEL 5001 MICROMANIPULATOR FOR USE W/TF-25 CO2 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | COHERENT MEDICAL GROUP 3270 W. BAYSHORE RD. P.O. BOX 10122 Palo Alto, CA 94303 |
| Contact | Virginia Singer |
| Correspondent | Virginia Singer COHERENT MEDICAL GROUP 3270 W. BAYSHORE RD. P.O. BOX 10122 Palo Alto, CA 94303 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-14 |
| Decision Date | 1987-11-10 |