The following data is part of a premarket notification filed by Richards Manufacturer Co. with the FDA for Arthroscopy Knives/probes/bending Tool.
Device ID | K831656 |
510k Number | K831656 |
Device Name: | ARTHROSCOPY KNIVES/PROBES/BENDING TOOL |
Classification | Arthroscope |
Applicant | RICHARDS MANUFACTURER CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-05-23 |
Decision Date | 1983-06-30 |