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510(k) K022156

LATEX ULTRASONIC PROBE COVER by Pleasure Latex Products Sdn. Bhd. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2003
Date Received
July 2, 2002
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

Other clearances by Pleasure Latex Products Sdn. Bhd.

  • K023333 — MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR (June 23, 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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