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510(k) K101832

BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT by Medical Device Technologies, Inc. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2010
Date Received
July 1, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy
Device Class
Class II
Regulation Number
876.1075
Review Panel
SU
Submission Type

Other clearances by Medical Device Technologies, Inc.

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  • K050873 — CANALIZER HYDROPHILIC GUIDE WIRE (May 26, 2005)
  • K043523 — INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE (February 11, 2005)
  • K042464 — V-CORE FULL CORE BREAST BIOPSY INSTRUMENT (September 30, 2004)
  • K040427 — FIBREX CATHETER PATENCY DEVICE (May 3, 2004)
  • K031442 — PBN GUIDEWIRES (August 13, 2003)
  • K021606 — EN-SNARE ENDOVASCULAR SNARE AND CATHETER (May 31, 2002)
  • K011790 — MICROCRUISER PLUS INTRODUCER SET (September 5, 2001)
  • K000620 — PBN FALLOPIAN TUBE CATHETER SYSTEM (October 30, 2000)

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