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510(k) K100518

INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 by Instrumed International, Inc. — Product Code DWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2010
Date Received
February 23, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Vessel, Surgical
Device Class
Class II
Regulation Number
870.4475
Review Panel
CV
Submission Type

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  • K092544 — INSTRUMED VASCULAR CLAMPS (October 26, 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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