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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, External Penile Rigidity
510(k) Number K955856
Device Name TEX-AID BLUE
Applicant
Laborie Medical Technologies, Ltd.
6415 Northwest Dr.
Unit 10
Mississauga Ont. Canada,  CA L4V1X1
Applicant Contact FRED BUFFA
Correspondent
Laborie Medical Technologies, Ltd.
6415 Northwest Dr.
Unit 10
Mississauga Ont. Canada,  CA L4V1X1
Correspondent Contact FRED BUFFA
Regulation Number876.5020
Classification Product Code
LKY  
Date Received12/26/1995
Decision Date 02/16/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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