The following data is part of a premarket notification filed by Cooper Lasersonics, Inc. with the FDA for Hs-15m Microwave Surgery Equipment, Microtaze.
| Device ID | K861904 |
| 510k Number | K861904 |
| Device Name: | HS-15M MICROWAVE SURGERY EQUIPMENT, MICROTAZE |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | COOPER LASERSONICS, INC. 3420 Central Expressway Santa Clara, CA 95051 |
| Contact | Charles Rose |
| Correspondent | Charles Rose COOPER LASERSONICS, INC. 3420 Central Expressway Santa Clara, CA 95051 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-16 |
| Decision Date | 1986-10-16 |