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510(k) K071771

INSTRUMED RETRACTORS by Instrumed International, Inc. — Product Code GZT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2007
Date Received
June 29, 2007
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor, Self-Retaining, For Neurosurgery
Device Class
Class II
Regulation Number
882.4800
Review Panel
NE
Submission Type

Other clearances by Instrumed International, Inc.

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  • K100517 — INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX (April 29, 2010)
  • K092840 — INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL (December 3, 2009)
  • K092544 — INSTRUMED VASCULAR CLAMPS (October 26, 2009)
  • K081651 — INSTRUMED RONGEUR (August 8, 2008)
  • K040855 — INSTRUMED LAPAROSCOPE AND ACCESSORIES (April 16, 2004)

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