The following data is part of a premarket notification filed by Cryomedical Sciences, Inc. with the FDA for Cms Blizzard 700 Series Models 730, 740,750,760,770,780 & 790.
| Device ID | K980668 |
| 510k Number | K980668 |
| Device Name: | CMS BLIZZARD 700 SERIES MODELS 730, 740,750,760,770,780 & 790 |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | CRYOMEDICAL SCIENCES, INC. 1300 PICCARD DR. Rockville, MD 20850 |
| Contact | Richard J Reinhard, Ph.d. |
| Correspondent | Richard J Reinhard, Ph.d. 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 | 1998-02-20 |
| Decision Date | 1998-07-17 |
| Summary: | summary |