FDA 510(k) Application Details - K834473

Device Classification Name Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days

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510(K) Number K834473
Device Name Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
Applicant BURRON MEDICAL PRODUCTS, INC.


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Regulation Number 880.5970

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Classification Product Code LJS
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Date Received 12/20/1983
Decision Date 04/30/1984
Decision SE - Substantially Equivalent
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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