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510(k) K053367

MALE NATURAL RUBBER LATEX CONDOM by Innolatex Sdn. Bhd — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2006
Date Received
December 5, 2005
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 Innolatex Sdn. Bhd

  • K041837 — INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED (September 24, 2004)
  • K012665 — ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT (November 9, 2001)
  • K012964 — 56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM (November 9, 2001)
  • K012962 — DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM (November 9, 2001)
  • K012664 — ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT (November 9, 2001)
  • K010919 — MALE NATURAL RUBBER LATEX CONDOM (June 15, 2001)
  • K010178 — SPERMICIDAL LUBRICATED MALE LATEX CONDOM (April 27, 2001)
  • K002393 — NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM (December 19, 2000)

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