FDA 510(k) Application Details - K971362

Device Classification Name Pump, Infusion, Elastomeric

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510(K) Number K971362
Device Name Pump, Infusion, Elastomeric
Applicant SCIENCE INCORPORATED
MINNESOTA CENTER
7760 FRANCE AVE, S., STE.1060
BLOOMINGTON, MN 55435 US
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Contact RALPH E HOGANCAMP
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Regulation Number 880.5725

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Classification Product Code MEB
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Date Received 04/11/1997
Decision Date 12/04/1997
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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