The following data is part of a premarket notification filed by Rinn Corp. with the FDA for Rinn E-z Capper.
Device ID | K913885 |
510k Number | K913885 |
Device Name: | RINN E-Z CAPPER |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | RINN CORP. 1212 ABBOTT DR. Elgin, IL 60123 -1819 |
Contact | Raymond G Jacobs |
Correspondent | Raymond G Jacobs RINN CORP. 1212 ABBOTT DR. Elgin, IL 60123 -1819 |
Product Code | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-08-29 |
Decision Date | 1991-12-13 |