The following data is part of a premarket notification filed by Cabot Medical Corp. with the FDA for Endocoagulator 2001 Kli.
| Device ID | K895402 |
| 510k Number | K895402 |
| Device Name: | ENDOCOAGULATOR 2001 KLI |
| Classification | Electrocautery, Gynecologic (and Accessories) |
| Applicant | CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne, PA 19047 |
| Contact | Carolyn Dejonge |
| Correspondent | Carolyn Dejonge 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 | 1989-09-07 |
| Decision Date | 1990-04-26 |