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510(k) K974357

UTERINE MANIPULATOR/INJECTOR by Catheter Research, Inc. — Product Code LKF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1998
Date Received
November 19, 1997
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

Other clearances by Catheter Research, Inc.

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  • K032835 — H/S CATHETER SET (December 11, 2003)
  • K020292 — UTERINE INJECTOR (April 17, 2002)
  • K973839 — DISPOSABLE ESOPHAGEAL STETHOSCOPE (March 19, 1998)
  • K951345 — DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING (April 14, 1995)
  • K946044 — DISPOSABLE GAS SAMPLING LINES (December 27, 1994)

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