The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Infusion Line.
Device ID | K912919 |
510k Number | K912919 |
Device Name: | MENTOR INFUSION LINE |
Classification | Accessories, Catheter, G-u |
Applicant | MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
Contact | Byron H Wickett |
Correspondent | Byron H Wickett MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
Product Code | KNY |
CFR Regulation Number | 876.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-07-03 |
Decision Date | 1991-12-13 |