FDA 510(k) Application Details - K070357

Device Classification Name Catheter, Steerable

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510(K) Number K070357
Device Name Catheter, Steerable
Applicant CRYOCATH TECHNOLOGIES, INC.
10 B TANO ROAD
SANTA FE, NM 87506 US
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Contact FRED MILDER
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Regulation Number 870.1280

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Classification Product Code DRA
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Date Received 02/07/2007
Decision Date 12/28/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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