FDA 510(k) Application Details - K001342

Device Classification Name Pump, Infusion, Elastomeric

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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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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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