FDA 510(k) Application Details - K051253

Device Classification Name Pump, Infusion, Pca

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510(K) Number K051253
Device Name Pump, Infusion, Pca
Applicant BAXTER HEALTHCARE CORP.
1620 WAUKEGAN ROAD
MCGAW PARK, IL 60085 US
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Contact NANETTE HEDDEN
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Regulation Number 880.5725

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Classification Product Code MEA
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Date Received 05/16/2005
Decision Date 07/15/2005
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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