The following data is part of a premarket notification filed by Cooper Lasersonics, Inc. with the FDA for Model Hse-5m Microwave Surgery Equipment/microtaze.
| Device ID | K864413 |
| 510k Number | K864413 |
| Device Name: | MODEL HSE-5M 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 L Rose |
| Correspondent | Charles L 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 | 1986-11-10 |
| Decision Date | 1986-12-09 |