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510(k) K020292

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2002
Date Received
January 28, 2002
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.

  • K123258 — THE ADVANCE CATHETER FOR HSG AND SIS (January 31, 2013)
  • K120154 — INTRAUTERINE INSEMINATION (IUI) CATHETER (March 21, 2012)
  • K032835 — H/S CATHETER SET (December 11, 2003)
  • K973839 — DISPOSABLE ESOPHAGEAL STETHOSCOPE (March 19, 1998)
  • K974357 — UTERINE MANIPULATOR/INJECTOR (February 2, 1998)
  • K951345 — DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING (April 14, 1995)
  • K946044 — DISPOSABLE GAS SAMPLING LINES (December 27, 1994)

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