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510(k) K081265

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2009
Date Received
May 5, 2008
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.

  • K142790 — OneTouch Lubricant Gel (July 30, 2015)
  • K032909 — THAI NIPPON EXTRA STRENGTH MALE LATEX CONDOM (December 16, 2003)
  • K011253 — FLAVORED MALE LATEX CONDOM (July 20, 2001)
  • K001978 — 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9 (August 8, 2000)
  • K994095 — LATEX CONDOM (January 18, 2000)

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