The following data is part of a premarket notification filed by Frigitronics Of Connecticut, Inc. with the FDA for Frigitronics Acc-1000 Capsule Cutter.
| Device ID | K872362 |
| 510k Number | K872362 |
| Device Name: | FRIGITRONICS ACC-1000 CAPSULE CUTTER |
| Classification | Unit, Phacofragmentation |
| Applicant | FRIGITRONICS OF CONNECTICUT, INC. 770 RIVER RD. P.O. BOX 855 Shelton, CT 06484 |
| Contact | Clifford F Potocky |
| Correspondent | Clifford F Potocky FRIGITRONICS OF CONNECTICUT, INC. 770 RIVER RD. P.O. BOX 855 Shelton, CT 06484 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-18 |
| Decision Date | 1987-07-27 |