The following data is part of a premarket notification filed by Lsi Solutions, Inc. with the FDA for Cor-knot Micro.
Device ID | K202551 |
510k Number | K202551 |
Device Name: | Cor-Knot Micro |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | LSI Solutions, Inc. 7796 Victor-Mendon Road Victor, NY 14564 |
Contact | Christopher B. Miller |
Correspondent | Christopher B. Miller LSI Solutions, Inc. 7796 Victor-Mendon Road Victor, NY 14564 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-09-03 |
Decision Date | 2021-06-24 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10850200006930 | K202551 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
COR-KNOT MICRO 88444924 not registered Live/Pending |
LSI Solutions, Inc. 2019-05-24 |