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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 K132490
Device Name SKORE AND MULTIPLE BRANDS
Applicant
TTK PROTECTIVE DEVICES LIMITED (FORMERLY TTK-LIG L
2871, COASTAL DR
AURORA,  IL  60503
Applicant Contact MANOJ ZACHARIAS
Correspondent
TTK PROTECTIVE DEVICES LIMITED (FORMERLY TTK-LIG L
2871, COASTAL DR
AURORA,  IL  60503
Correspondent Contact MANOJ ZACHARIAS
Regulation Number884.5300
Classification Product Code
HIS  
Date Received08/08/2013
Decision Date 10/20/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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