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510(k) K031463

MARINA MEDICAL SILICONE PESSARY by Marina Medical Instruments, Inc. — Product Code HHW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2003
Date Received
May 8, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pessary, Vaginal
Device Class
Class II
Regulation Number
884.3575
Review Panel
OB
Submission Type

Other clearances by Marina Medical Instruments, Inc.

  • K042534 — MARINA MEDICAL FINGER PROTECTORS (May 10, 2005)
  • K021876 — MAS WITH OR WITHOUT SYRINGE (April 8, 2003)
  • K023725 — HEMORRHAGE OCCLUDER PIN (HOP), MODEL 337-247 (February 3, 2003)
  • K010296 — UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450 (April 11, 2001)

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