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510(k) K011253

FLAVORED MALE LATEX CONDOM by Thai Nippon Rubber Industry Co., Ltd. — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2001
Date Received
April 24, 2001
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

Other clearances by Thai Nippon Rubber Industry Co., Ltd.

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  • K081265 — THAI NIPPON MALE LATEX CONDOM (October 16, 2009)
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  • K001978 — 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9 (August 8, 2000)
  • K994095 — LATEX CONDOM (January 18, 2000)

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