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U.S. Department of Health and Human Services

510(k) Premarket Notification

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11 to 20 of 383 Results
ProductCode: HIS Decision Date To: 08/27/2018
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510(K)
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royal condoms (natural, black grape, coffee, strawberry, and chocolate flavors) M3 GLOBAL ENTERPRISES, LLC K161195 08/25/2016
lelo hex natural rubber latex condom LELO Inc. K160644 06/30/2016
o-ring condom O-RING Products LLC K150828 12/18/2015
banana gold HANKOOK LATEX GONGUP CO., LTD. K150857 08/14/2015
theyfit male condom THEYFIT K150072 04/14/2015
skore and multiple brands TTK PROTECTIVE DEVICES LIMITED (FORMERLY TTK-LIG L K132490 10/20/2014
natural rubber latex male condoms KAREX INDUSTRIES SDN BHD K141059 08/01/2014
okamoto studded condom OKAMOTO U.S.A., INC. K141256 07/23/2014
mega big boy condom OKAMOTO U.S.A., INC. K140379 07/01/2014
sustain HOLLENDER SUSTAINABLE BRANDS LLC K131866 05/01/2014
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