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510(k) K092544

INSTRUMED VASCULAR CLAMPS by Instrumed International, Inc. — Product Code DXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2009
Date Received
August 19, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Vascular
Device Class
Class II
Regulation Number
870.4450
Review Panel
CV
Submission Type

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  • K092840 — INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL (December 3, 2009)
  • K081651 — INSTRUMED RONGEUR (August 8, 2008)
  • K071771 — INSTRUMED RETRACTORS (August 2, 2007)
  • K040855 — INSTRUMED LAPAROSCOPE AND ACCESSORIES (April 16, 2004)

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