FDA 510(k) Application Details - K841828

Device Classification Name Catheter, Percutaneous

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510(K) Number K841828
Device Name Catheter, Percutaneous
Applicant NORTON PERFORMANCE PLASTICS CORP.

, US
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Regulation Number 870.1250

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Classification Product Code DQY
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Date Received 05/03/1984
Decision Date 07/13/1984
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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