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510(k) K141059

NATURAL RUBBER LATEX MALE CONDOMS by Karex Industries Sdn. Bhd. — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2014
Date Received
April 24, 2014
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condom
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type

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  • K113061 — LARGE/EXTRA LAGRE CONDOM (December 7, 2011)
  • K081886 — KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED A (February 6, 2009)
  • K070830 — MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORING) (May 8, 2007)

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