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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 K051273
Device Name DIVAS DUAL PLEASURE MALE LATEX CONDOM
Applicant
EAGLE TWE, INC.
2090 TUCKER INDUSTRIAL ROAD
SUITE A-5
TUCKER,  GA  30084
Applicant Contact BILL TAFFS
Correspondent
EAGLE TWE, INC.
2090 TUCKER INDUSTRIAL ROAD
SUITE A-5
TUCKER,  GA  30084
Correspondent Contact BILL TAFFS
Regulation Number884.5300
Classification Product Code
HIS  
Date Received05/17/2005
Decision Date 08/19/2005
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
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