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FDA 510(k) Application Details - K021010
Device Classification Name
Surgical Device, For Ablation Of Cardiac Tissue
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510(K) Number
K021010
Device Name
Surgical Device, For Ablation Of Cardiac Tissue
Applicant
ENDOCARE, INC.
7 STUDEBAKER
IRVINE, CA 92618 US
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Contact
EBEN GORDON
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Regulation Number
878.4400
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Classification Product Code
OCL
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More FDA Info for this Product Code
Date Received
03/29/2002
Decision Date
06/06/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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