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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom
510(k) Number K041717
Device Name POWERSTICK MALE LATEX CONDOMS
Applicant
A.P.Deauville, LLC
594 Jersey Ave.
New Brunswick,  NJ  08901
Applicant Contact SCOTT L BAIER
Correspondent
A.P.Deauville, LLC
594 Jersey Ave.
New Brunswick,  NJ  08901
Correspondent Contact SCOTT L BAIER
Regulation Number884.5300
Classification Product Code
HIS  
Date Received06/24/2004
Decision Date 01/13/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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