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510(k) K093512

ENCOR BREAST BIOPSY SYSTEM by Senorx, Inc. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2009
Date Received
November 13, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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  • K081079 — CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY (May 2, 2008)
  • K080791 — CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 (April 30, 2008)

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