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510(k) K002393

NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM by Innolatex Sdn. Bhd — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2000
Date Received
August 7, 2000
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)
  • K041837 — INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED (September 24, 2004)
  • K012962 — DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM (November 9, 2001)
  • K012964 — 56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM (November 9, 2001)
  • K012665 — ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT (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)

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