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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Penile Tumescence
510(k) Number K991479
Device Name VISER PENILE TUMESCENCE MONITOR
Applicant
Laborie Medical Tech Corp.
310 Hurricane Ln. #2
Williston,  VT  05495
Applicant Contact DALE COLEMAN
Correspondent
Laborie Medical Tech Corp.
310 Hurricane Ln. #2
Williston,  VT  05495
Correspondent Contact DALE COLEMAN
Classification Product Code
LIL  
Date Received04/28/1999
Decision Date 07/07/1999
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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