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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 K946207
Device Name CONQUEROR, RUMBA AND TEMPTATION
Applicant
FRONTLINE LATEX PRODUCTS PVT. LTD.
57 WEST 38TH ST.
2ND FLOOR
NEW YORK,  NY  10018 -5500
Applicant Contact ASHEEM AGGARWAL
Correspondent
FRONTLINE LATEX PRODUCTS PVT. LTD.
57 WEST 38TH ST.
2ND FLOOR
NEW YORK,  NY  10018 -5500
Correspondent Contact ASHEEM AGGARWAL
Regulation Number884.5300
Classification Product Code
HIS  
Date Received12/21/1994
Decision Date 01/24/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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