FDA 510(k) Application Details - K002273

Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

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510(K) Number K002273
Device Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant STOECKERT INSTRUMENTE
14401 W. 65th Way
Arvada, CO 80004-3599 US
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Contact BARBARA WATSON
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Regulation Number 870.4210

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Classification Product Code DWF
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Date Received 07/26/2000
Decision Date 01/29/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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