FDA 510(k) Application Details - K962663

Device Classification Name Pump, Infusion, Elastomeric

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510(K) Number K962663
Device Name Pump, Infusion, Elastomeric
Applicant SOLOPAK MEDICAL PRODUCTS, INC.
RON0 INDUSTRIAL DR.
SUITE 200
LIBERTYVILLE, IL 60048 US
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Contact RON HASELHARST
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Regulation Number 880.5725

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Classification Product Code MEB
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Date Received 07/08/1996
Decision Date 10/04/1996
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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