The following data is part of a premarket notification filed by Rinn Corp. with the FDA for Rinn Universal Collimator.
Device ID | K932134 |
510k Number | K932134 |
Device Name: | RINN UNIVERSAL COLLIMATOR |
Classification | Collimator, Manual, Radiographic |
Applicant | RINN CORP. 1212 ABBOTT DR. Elgin, IL 60123 -1819 |
Contact | Raymond Jacobs |
Correspondent | Raymond Jacobs RINN CORP. 1212 ABBOTT DR. Elgin, IL 60123 -1819 |
Product Code | IZX |
CFR Regulation Number | 892.1610 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-03 |
Decision Date | 1993-07-26 |