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FDA 510(k) Application Details - K001342
Device Classification Name
Pump, Infusion, Elastomeric
More FDA Info for this Device
510(K) Number
K001342
Device Name
Pump, Infusion, Elastomeric
Applicant
POST OPERATIVE PAIN MANAGEMENT
1 CORPORATE CENTER
BROADVIEW HEIGHTS, OH 44147 US
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Contact
CHARLES ROWLAND II
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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
04/27/2000
Decision Date
09/07/2000
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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