The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Lubricating Jelly.
Device ID | K910790 |
510k Number | K910790 |
Device Name: | MENTOR LUBRICATING JELLY |
Classification | Lubricant, Patient |
Applicant | MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
Contact | Lynn R Breckenridge |
Correspondent | Lynn R Breckenridge MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
Product Code | KMJ |
CFR Regulation Number | 880.6375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-02-25 |
Decision Date | 1991-05-03 |