The following data is part of a premarket notification filed by Everest Medical Corp. with the FDA for Monopolar Pollypectomy Snare.
Device ID | K911700 |
510k Number | K911700 |
Device Name: | MONOPOLAR POLLYPECTOMY 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 | 1991-04-16 |
Decision Date | 1991-07-01 |