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FDA 510(k) Application Details - K110826
Device Classification Name
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510(K) Number
K110826
Device Name
CUROS PORT PROTECTOR
Applicant
IVERA MEDICAL
2731 LOKER AVENUE WEST
CARLSBAD, CA 92010 US
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Contact
DON CANAL
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Regulation Number
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Classification Product Code
QBP
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Date Received
03/24/2011
Decision Date
06/23/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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