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FDA 510(k) Application Details - K093565
Device Classification Name
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510(K) Number
K093565
Device Name
PLEURAFLOW CATHETER SYSTEM
Applicant
CLEAR CATHETER SYSTEMS
901 KING ST., SUITE 200
ALEXANDRIA, VA 22314 US
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Contact
MONICA DOUGHERTY
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Regulation Number
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Classification Product Code
OTK
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Date Received
11/18/2009
Decision Date
12/03/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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