MENTOR CORPORAL DILATORS

Prosthesis, Penile

MENTOR CORP.

The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Corporal Dilators.

Pre-market Notification Details

Device IDK860517
510k NumberK860517
Device Name:MENTOR CORPORAL DILATORS
ClassificationProsthesis, Penile
Applicant MENTOR CORP. 600 PINE AVE. Goleta,  CA  93117
ContactKaren Edwards
CorrespondentKaren Edwards
MENTOR CORP. 600 PINE AVE. Goleta,  CA  93117
Product CodeFAE  
CFR Regulation Number876.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-02-11
Decision Date1986-03-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.