The following data is part of a premarket notification filed by Cabot Medical Corp. with the FDA for Cabot Arthroscopy System.
Device ID | K833727 |
510k Number | K833727 |
Device Name: | CABOT ARTHROSCOPY SYSTEM |
Classification | Arthroscope |
Applicant | CABOT MEDICAL CORP. 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 | 1983-11-14 |
Decision Date | 1983-12-12 |