The following data is part of a premarket notification filed by Kaycor Intl., Ltd. with the FDA for Yoshida Rido-f, Model Lm-01.
Device ID | K813348 |
510k Number | K813348 |
Device Name: | YOSHIDA RIDO-F, MODEL LM-01 |
Classification | Handpiece, Direct Drive, Ac-powered |
Applicant | KAYCOR INTL., LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | EKX |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-11-27 |
Decision Date | 1982-01-07 |