The following data is part of a premarket notification filed by Kaycor Intl., Ltd. with the FDA for Yoshida/kaycor X-707 Wall Mounted Dental X-ray.
Device ID | K931717 |
510k Number | K931717 |
Device Name: | YOSHIDA/KAYCOR X-707 WALL MOUNTED DENTAL X-RAY |
Classification | Unit, X-ray, Intraoral |
Applicant | KAYCOR INTL., LTD. 3611 COMMERCIAL AVE. Northbrook, IL 60062 |
Contact | Keith R Kretchmer |
Correspondent | Keith R Kretchmer KAYCOR INTL., LTD. 3611 COMMERCIAL AVE. Northbrook, IL 60062 |
Product Code | EAP |
CFR Regulation Number | 872.1810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-06 |
Decision Date | 1993-09-20 |