MENTOR MODIFIED MALLEABLE PENILE PROSTHESES

Prosthesis, Penile

MENTOR CORP.

The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Modified Malleable Penile Prostheses.

Pre-market Notification Details

Device IDK900371
510k NumberK900371
Device Name:MENTOR MODIFIED MALLEABLE PENILE PROSTHESES
ClassificationProsthesis, Penile
Applicant MENTOR CORP. 600 PINE AVE. Goleta,  CA  93117
ContactTerry A Thompson
CorrespondentTerry A Thompson
MENTOR CORP. 600 PINE AVE. Goleta,  CA  93117
Product CodeFAE  
CFR Regulation Number876.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-01-26
Decision Date1990-11-02

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