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510(k) K081651

INSTRUMED RONGEUR by Instrumed International, Inc. — Product Code HAE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2008
Date Received
June 12, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rongeur, Manual
Device Class
Class II
Regulation Number
882.4840
Review Panel
NE
Submission Type

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  • K092840 — INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL (December 3, 2009)
  • K092544 — INSTRUMED VASCULAR CLAMPS (October 26, 2009)
  • K071771 — INSTRUMED RETRACTORS (August 2, 2007)
  • K040855 — INSTRUMED LAPAROSCOPE AND ACCESSORIES (April 16, 2004)

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