TEX-AID BLUE

Device, External Penile Rigidity

LABORIE MEDICAL TECHNOLOGIES, LTD.

The following data is part of a premarket notification filed by Laborie Medical Technologies, Ltd. with the FDA for Tex-aid Blue.

Pre-market Notification Details

Device IDK955856
510k NumberK955856
Device Name:TEX-AID BLUE
ClassificationDevice, External Penile Rigidity
Applicant LABORIE MEDICAL TECHNOLOGIES, LTD. 6415 NORTHWEST DR. UNIT 10 Mississauga Ont. Canada,  CA L4v1x1
ContactFred Buffa
CorrespondentFred Buffa
LABORIE MEDICAL TECHNOLOGIES, LTD. 6415 NORTHWEST DR. UNIT 10 Mississauga Ont. Canada,  CA L4v1x1
Product CodeLKY  
CFR Regulation Number876.5020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-12-26
Decision Date1996-02-16

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