FDA 510(k) Application Details - K972084

Device Classification Name Monitor, Electric For Gravity Flow Infusion Systems

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510(K) Number K972084
Device Name Monitor, Electric For Gravity Flow Infusion Systems
Applicant ALEXANDER MFG. CO.
1511 S GARFIELD PL
MASON CITY, IA 50401 US
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Contact KEN HEIMENDINGER
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Regulation Number 880.2420

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Classification Product Code FLN
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Date Received 06/04/1997
Decision Date 07/03/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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