The following data is part of a premarket notification filed by Cryomedical Sciences, Inc. with the FDA for Cms Accuprobe 610, 620, 630, 640, 650, 660, 670, 680.
| Device ID | K964336 |
| 510k Number | K964336 |
| Device Name: | CMS ACCUPROBE 610, 620, 630, 640, 650, 660, 670, 680 |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | CRYOMEDICAL SCIENCES, INC. 1300 PICCARD DR. Rockville, MD 20850 |
| Contact | Richard J Reinhart |
| Correspondent | Richard J Reinhart CRYOMEDICAL SCIENCES, INC. 1300 PICCARD DR. Rockville, MD 20850 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-31 |
| Decision Date | 1997-03-20 |
| Summary: | summary |