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 |