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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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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