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FDA 510(k) Application Details - K110958
Device Classification Name
Lavage, Jet
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510(K) Number
K110958
Device Name
Lavage, Jet
Applicant
SMITH & NEPHEW, INC.
970 LAKE CARILLON DR.
SUITE 110
ST. PETERSBURG, FL 33716 US
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Contact
LAURA REYNOLDS
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Regulation Number
880.5475
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Classification Product Code
FQH
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Date Received
04/05/2011
Decision Date
08/01/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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