The following data is part of a premarket notification filed by Cryomedical Sciences, Inc. with the FDA for Accuprobe 800 Series Model Numbers : 810, 820, 830, 840, 850, 860, 870 And 880.
| Device ID | K982055 |
| 510k Number | K982055 |
| Device Name: | ACCUPROBE 800 SERIES MODEL NUMBERS : 810, 820, 830, 840, 850, 860, 870 AND 880 |
| 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 | 1998-06-11 |
| Decision Date | 1998-09-08 |
| Summary: | summary |