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510(k) K010919

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2001
Date Received
March 27, 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 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)
  • K010178 — SPERMICIDAL LUBRICATED MALE LATEX CONDOM (April 27, 2001)
  • K002393 — NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM (December 19, 2000)

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