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510(k) K063611

SALINE/ CONTRAST MEDIA INFUSION CATHETER by Utah Medical Products, Inc. — Product Code LKF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2007
Date Received
December 3, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Manipulator/Injector, Uterine
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

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  • K000974 — FOWLER ENDOCURETTE, MODEL CUR-XXX (May 23, 2000)
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  • K955663 — ABC IN-LINE BLOOD SAMPLING KIT (March 17, 1997)
  • K964526 — LIBERTY RECTAL PELVIC FLOOR EXERCISER (February 10, 1997)
  • K961424 — INTRAN 500 (July 10, 1996)

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