The following data is part of a premarket notification filed by Frigitronics Of Connecticut, Inc. with the FDA for Mic-100 With Cryoprobes.
| Device ID | K891282 |
| 510k Number | K891282 |
| Device Name: | MIC-100 WITH CRYOPROBES |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | FRIGITRONICS OF CONNECTICUT, INC. 770 RIVER RD. P.O. BOX 855 Shelton, CT 06484 |
| Contact | Frank Hallett |
| Correspondent | Frank Hallett FRIGITRONICS OF CONNECTICUT, INC. 770 RIVER RD. P.O. BOX 855 Shelton, CT 06484 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-09 |
| Decision Date | 1989-06-15 |