MENTOR CYLINDER PROTECTOR TOOL (INFLATABLE PENILE)

Prosthesis, Penile

MENTOR CORP.

The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Cylinder Protector Tool (inflatable Penile).

Pre-market Notification Details

Device IDK890402
510k NumberK890402
Device Name:MENTOR CYLINDER PROTECTOR TOOL (INFLATABLE PENILE)
ClassificationProsthesis, Penile
Applicant MENTOR CORP. 600 PINE AVE. Goleta,  CA  93117
ContactByron Wickett
CorrespondentByron Wickett
MENTOR CORP. 600 PINE AVE. Goleta,  CA  93117
Product CodeFAE  
CFR Regulation Number876.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-01-24
Decision Date1989-08-03

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