The following data is part of a premarket notification filed by Medtech Industries, Inc. with the FDA for Arthroscopy Knives.
Device ID | K842820 |
510k Number | K842820 |
Device Name: | ARTHROSCOPY KNIVES |
Classification | Knife, Orthopedic |
Applicant | MEDTECH INDUSTRIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | HTS |
CFR Regulation Number | 888.4540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-07-19 |
Decision Date | 1984-08-14 |