U-TEX

Clamp, Penile

LABORIE MEDICAL TECHNOLOGIES, LTD.

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

Pre-market Notification Details

Device IDK955810
510k NumberK955810
Device Name:U-TEX
ClassificationClamp, Penile
Applicant LABORIE MEDICAL TECHNOLOGIES, LTD. 6415 NORTHWEST DR. UNIT 11 Mississauga (ontario),  CA L4v 1x1
ContactFred Buffa
CorrespondentFred Buffa
LABORIE MEDICAL TECHNOLOGIES, LTD. 6415 NORTHWEST DR. UNIT 11 Mississauga (ontario),  CA L4v 1x1
Product CodeFHA  
CFR Regulation Number876.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-12-26
Decision Date1996-01-24

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