The following data is part of a premarket notification filed by Frigitronics Of Connecticut, Inc. with the FDA for Ccs100 Cryosurgical System.
| Device ID | K811390 |
| 510k Number | K811390 |
| Device Name: | CCS100 CRYOSURGICAL SYSTEM |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | FRIGITRONICS OF CONNECTICUT, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-18 |
| Decision Date | 1981-06-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818354010039 | K811390 | 000 |
| 00818354010022 | K811390 | 000 |
| 00818354010015 | K811390 | 000 |
| 00818354010008 | K811390 | 000 |
| 00818354014761 | K811390 | 000 |