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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 K050913
Device Name DICK'S FORMALWEAR MALE LATEX CONDOM
Applicant
DICK'S FORMALWEAR INC.
3507 W. BETHANY HOME ROAD
phoenix,  AZ  85019
Applicant Contact curt strenk
Correspondent
DICK'S FORMALWEAR INC.
3507 W. BETHANY HOME ROAD
phoenix,  AZ  85019
Correspondent Contact curt strenk
Regulation Number884.5300
Classification Product Code
HIS  
Date Received04/12/2005
Decision Date 04/04/2006
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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