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FDA 510(k) Application Details - K051819
Device Classification Name
Warmer, Irrigation Solution
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510(K) Number
K051819
Device Name
Warmer, Irrigation Solution
Applicant
C CHANGE SURGICAL LLC
101 NORTH CHESTNUT STREET
SUITE 301
WINSTON-SALEM, NC 27101 US
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Contact
ROBERT KELLY
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Regulation Number
000.0000
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Classification Product Code
LHC
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More FDA Info for this Product Code
Date Received
07/05/2005
Decision Date
08/15/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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