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FDA 510(k) Application Details - K050916
Device Classification Name
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510(K) Number
K050916
Device Name
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [PERIPHERAL]
Applicant
INTRALUMINAL THERAPEUTICS, INC.
6354 CORTE DEL ABETO
SUITE A
CARLSBAD, CA 92009 US
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Contact
PAMELA MISAJON
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Regulation Number
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Classification Product Code
PDU
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Date Received
04/12/2005
Decision Date
06/08/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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