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FDA 510(k) Application Details - K955515
Device Classification Name
Microfilter, Blood Transfusion
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510(K) Number
K955515
Device Name
Microfilter, Blood Transfusion
Applicant
ALPHA THERAPEUTIC CORP.
5555 VALLEY BLVD.
LOS ANGELES, CA 90032 US
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Contact
M. SUE PRESTON
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Regulation Number
880.5440
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Classification Product Code
CAK
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More FDA Info for this Product Code
Date Received
12/04/1995
Decision Date
02/12/1996
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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