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510(k) K041837

INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED by Innolatex Sdn. Bhd — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2004
Date Received
July 7, 2004
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

  • K053367 — MALE NATURAL RUBBER LATEX CONDOM (February 21, 2006)
  • K012665 — ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT (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)
  • K012964 — 56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM (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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