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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 K052929
Device Name PREFTEST PROFESSIONAL SUITE
Applicant
Limestone Technologies, Inc.
4 Innovation Dr.
Dundas,  CA L9H 7P3
Applicant Contact NANCY RUTH
Correspondent
Limestone Technologies, Inc.
4 Innovation Dr.
Dundas,  CA L9H 7P3
Correspondent Contact NANCY RUTH
Classification Product Code
LIL  
Date Received10/19/2005
Decision Date 04/26/2006
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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