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510(k) K010296

UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450 by Marina Medical Instruments, Inc. — Product Code LKF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2001
Date Received
January 31, 2001
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 Marina Medical Instruments, Inc.

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  • K023725 — HEMORRHAGE OCCLUDER PIN (HOP), MODEL 337-247 (February 3, 2003)

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