The following data is part of a premarket notification filed by Kamiya Tsusan Kaisha, Ltd. with the FDA for Arthroscope-various Models Fiberoptic.
Device ID | K832341 |
510k Number | K832341 |
Device Name: | ARTHROSCOPE-VARIOUS MODELS FIBEROPTIC |
Classification | Arthroscope |
Applicant | KAMIYA TSUSAN KAISHA, LTD. CPO BOX 1590 TOKYO 100-91 JAPAN , |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-12 |
Decision Date | 1983-10-04 |