The following data is part of a premarket notification filed by Biological & Environmental Control Laboratories with the FDA for Microknife.
Device ID | K821769 |
510k Number | K821769 |
Device Name: | MICROKNIFE |
Classification | Knife, Surgical |
Applicant | BIOLOGICAL & ENVIRONMENTAL CONTROL LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EMF |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-06-10 |
Decision Date | 1982-09-14 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MICROKNIFE 86516036 5005233 Live/Registered |
Sonex Health, LLC 2015-01-27 |