The following data is part of a premarket notification filed by Cabot Medical Corp. with the FDA for Cabot Medical Reusable Bipolar Cutting Forceps.
Device ID | K946109 |
510k Number | K946109 |
Device Name: | CABOT MEDICAL REUSABLE BIPOLAR CUTTING FORCEPS |
Classification | Unit, Electrosurgical, Endoscopic (with Or Without 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 | KNS |
CFR Regulation Number | 876.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-12-14 |
Decision Date | 1995-11-21 |