FDA 510(k) Application Details - K070201

Device Classification Name

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510(K) Number K070201
Device Name BARD INTRA-ABDOMINAL PRESSURE MONITORING DEVICE, MODEL IAP-001
Applicant C.R. BARD, INC.
8195 INDUSTRIAL BLVD.
COVINGTON, GA 30014 US
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Contact MICHELLE GUDITH
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Regulation Number

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Classification Product Code PHU
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Date Received 01/22/2007
Decision Date 08/01/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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