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FDA 510(k) Application Details - K060986
Device Classification Name
Holder, Infant Position
More FDA Info for this Device
510(K) Number
K060986
Device Name
Holder, Infant Position
Applicant
STEVEN H. WARNOCK, M.D.
9829 S. 1300 E., SUITE 200
SANDY, UT 84094 US
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Contact
STEVEN H WARNOCK
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Regulation Number
880.5680
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Classification Product Code
FRP
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More FDA Info for this Product Code
Date Received
04/10/2006
Decision Date
07/11/2006
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
FDA Source Information for K060986
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