The following data is part of a premarket notification filed by Rinn Dental Products with the FDA for Rinn Protective X-ray Apron And Protective Collar.
Device ID | K913621 |
510k Number | K913621 |
Device Name: | RINN PROTECTIVE X-RAY APRON AND PROTECTIVE COLLAR |
Classification | Apron, Leaded |
Applicant | RINN DENTAL PRODUCTS 1212 ABBOTT DR. Elgin, IL 60123 |
Contact | Raymond G Jacobs |
Correspondent | Raymond G Jacobs RINN DENTAL PRODUCTS 1212 ABBOTT DR. Elgin, IL 60123 |
Product Code | EAJ |
CFR Regulation Number | 892.6500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-08-13 |
Decision Date | 1991-09-27 |