FDA 510(k) Application Details - K023872

Device Classification Name Catheter, Straight

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510(K) Number K023872
Device Name Catheter, Straight
Applicant VITALCARE, INC.
15800 NW 13TH AVE.
MIAMI, FL 33169 US
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Contact MICHAEL MCAVENIA
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Regulation Number 876.5130

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Classification Product Code EZD
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Date Received 11/20/2002
Decision Date 04/10/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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