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510(k) K001203

OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT by The Olympus Optical Co. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2000
Date Received
April 13, 2000
Clearance Type
Traditional
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

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  • K023767 — UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES (November 29, 2002)
  • K012074 — XBO1-824-18/19/20 BIOPSY FORCEPS (September 25, 2001)
  • K012073 — OLYMPUS SPRAY CATHETER PW-6C-1 (August 10, 2001)
  • K011869 — XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT (July 25, 2001)
  • K011149 — DISPOSABLE BENDING CANNULA PR-233Q (May 15, 2001)

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