The following data is part of a premarket notification filed by Clinical Technology Corp. with the FDA for Disposable Arthroscopy Cannula Set.
Device ID | K813000 |
510k Number | K813000 |
Device Name: | DISPOSABLE ARTHROSCOPY CANNULA SET |
Classification | Orthopedic Manual Surgical Instrument |
Applicant | CLINICAL TECHNOLOGY CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LXH |
CFR Regulation Number | 888.4540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-10-26 |
Decision Date | 1982-01-22 |