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510(k) K083802

SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025 by Medi-Globe Corporation — Product Code FCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2009
Date Received
December 22, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biopsy Needle
Device Class
Class II
Regulation Number
876.1075
Review Panel
GU
Submission Type

Other clearances by Medi-Globe Corporation

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  • K091257 — MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM (May 8, 2009)
  • K070129 — SONOTIP II ULTRASOUND NEEDLE SYSTEM (January 31, 2007)
  • K061684 — MEDI-GLOBE ROTA-CUT SPHINCTEROTOME (June 27, 2006)

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