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510(k) K023333

MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOUR by Pleasure Latex Products Sdn. Bhd. — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2003
Date Received
October 7, 2002
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 Pleasure Latex Products Sdn. Bhd.

  • K022156 — LATEX ULTRASONIC PROBE COVER (September 11, 2003)
  • K021875 — MALE LATEX CONDOM WITH DOTTED/RIBBED SURFACE AND COUNOUR-WALLED SHAPE (3 IN 1 UL (September 5, 2002)
  • K020272 — MALE LATEX CONDOM WITH RIBBED SURFACE (April 26, 2002)
  • K002571 — MULITPLE MALE LATX CONDOM (November 16, 2000)
  • K001377 — SPERMICIDAL LUBRICATED MALE LATEX CONDOM (June 8, 2000)
  • K001221 — MALE LATEX COMDOM WITH DOTTED SURFACE (May 19, 2000)
  • K994312 — MALE LATEX CONDOM 56MM (March 21, 2000)
  • K994311 — MALE LATEX CONDOM WITH VANILLA FLAVOR (March 21, 2000)
  • K982380 — SURE (February 26, 1999)

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