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FDA 510(k) Application Details - K963355
Device Classification Name
Pump, Infusion, Elastomeric
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510(K) Number
K963355
Device Name
Pump, Infusion, Elastomeric
Applicant
SOLOPAK MEDICAL PRODUCTS, INC.
1840 INDUSTRIAL DR.
SUITE 100
LIBERTYVILLE, IL 60048 US
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Contact
RON HASELHORST
Other 510(k) Applications for this Contact
Regulation Number
880.5725
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Classification Product Code
MEB
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More FDA Info for this Product Code
Date Received
08/26/1996
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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