The following data is part of a premarket notification filed by Cabot Medical Corp. with the FDA for Cryomedics Lletz Loops.
| Device ID | K923570 |
| 510k Number | K923570 |
| Device Name: | CRYOMEDICS LLETZ LOOPS |
| Classification | Electrocautery, Gynecologic (and Accessories) |
| Applicant | CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne, PA 19047 |
| Contact | Todd J Polk |
| Correspondent | Todd J Polk CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne, PA 19047 |
| Product Code | HGI |
| CFR Regulation Number | 884.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-17 |
| Decision Date | 1994-02-28 |