SENSATION -VACUUM ASSIST DEVICES

Device, External Penile Rigidity

PROSURG, INC.

The following data is part of a premarket notification filed by Prosurg, Inc. with the FDA for Sensation -vacuum Assist Devices.

Pre-market Notification Details

Device IDK000124
510k NumberK000124
Device Name:SENSATION -VACUUM ASSIST DEVICES
ClassificationDevice, External Penile Rigidity
Applicant PROSURG, INC. 2193 TRADE ZONE BLVD. San Jose,  CA  95131
ContactLee Bui
CorrespondentLee Bui
PROSURG, INC. 2193 TRADE ZONE BLVD. San Jose,  CA  95131
Product CodeLKY  
CFR Regulation Number876.5020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-01-18
Decision Date2000-07-10

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