The following data is part of a premarket notification filed by Utah Medical Products, Inc. with the FDA for Irrigation Set.
Device ID | K822560 |
510k Number | K822560 |
Device Name: | IRRIGATION SET |
Classification | Accessories, Arthroscopic |
Applicant | UTAH MEDICAL PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | NBH |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-08-24 |
Decision Date | 1982-12-03 |