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510(k) K003528

SANARUS CORE TISSUE BIOPSY SYSTEM by Endocare, Inc. — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2001
Date Received
November 16, 2000
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

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  • K021010 — MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE (June 6, 2002)
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  • K011074 — CRYOCARE SURGICAL SYSTEM (January 25, 2002)
  • K003811 — CRYOCARE SURGICAL SYSTEM (October 11, 2001)

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