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510(k) K932394

BERNSTEIN(TM) UTERINE MANIPULATOR by Gm Engineering, Inc. — Product Code LKF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1995
Date Received
May 18, 1993
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 Gm Engineering, Inc.

  • K953348 — ARTICULATING RETRACTOR TISSUE RETRACTORS (September 12, 1995)
  • K942626 — CONTINUOUS FLOW BIOPSY PROBE (May 30, 1995)
  • K941661 — GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT (August 23, 1994)
  • K942703 — GM REUSABLE AND DISPOSABLE TROCAR AND GM REUSABLE AND DISPOSABLE ULTRA-LIGHT CAN (August 19, 1994)
  • K941662 — GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT (July 20, 1994)
  • K941660 — GM OPTI*CAM CAMERA WITH FIBER OPTIC LIGHT (May 24, 1994)
  • K933962 — GM CONTINUOUS FLOW BIOPSY PROBE (February 25, 1994)
  • K930611 — TRUE FLOW(TM) VALVE (December 1, 1993)
  • K934035 — GM MONOPOLAR/FRAZIER SUCTION PROBE (December 1, 1993)
  • K931398 — GM SWIVEL VIDEO (TM) IRRIGATOR (August 30, 1993)

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