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FDA 510(k) Application Details - K974180
Device Classification Name
Container, I.V.
More FDA Info for this Device
510(K) Number
K974180
Device Name
Container, I.V.
Applicant
PHARMACY, INC.
3234 ELLA LN.
NEW PORT RICHEY, FL 34655 US
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ED RANSOM
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Regulation Number
880.5025
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Classification Product Code
KPE
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More FDA Info for this Product Code
Date Received
11/06/1997
Decision Date
02/24/1998
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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