The following data is part of a premarket notification filed by Cryomedical Sciences, Inc. with the FDA for Accuprobe 450, Accuprobe 550/530 And The Accuprobe 600 Series.
| Device ID | K973190 |
| 510k Number | K973190 |
| Device Name: | ACCUPROBE 450, ACCUPROBE 550/530 AND THE ACCUPROBE 600 SERIES |
| Classification | Electrosurgical, Cutting & Coagulation & 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 | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-25 |
| Decision Date | 1997-11-21 |
| Summary: | summary |