The following data is part of a premarket notification filed by Everest Medical Corp. with the FDA for Monopolar Coagulating Polypectomy Snare.
Device ID | K920089 |
510k Number | K920089 |
Device Name: | MONOPOLAR COAGULATING POLYPECTOMY SNARE |
Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
Applicant | EVEREST MEDICAL CORP. 13755 FIRST AVENUE NORTH Minneapolis, MN 55441 |
Contact | David J Parins |
Correspondent | David J Parins EVEREST MEDICAL CORP. 13755 FIRST AVENUE NORTH Minneapolis, MN 55441 |
Product Code | KNS |
CFR Regulation Number | 876.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-01-08 |
Decision Date | 1992-03-31 |