FDA 510(k) Application Details - K041890

Device Classification Name Surgical Device, For Ablation Of Cardiac Tissue

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510(K) Number K041890
Device Name Surgical Device, For Ablation Of Cardiac Tissue
Applicant CRYOCOR, INC.
9717 PACIFIC HEIGHTS BLVD.
SAN DIEGO, CA 92121 US
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Contact JAMI MILLER
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Regulation Number 878.4400

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Classification Product Code OCL
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Date Received 07/12/2004
Decision Date 09/22/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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