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FDA 510(k) Application Details - K030813
Device Classification Name
Catheter, Retention Type, Balloon
More FDA Info for this Device
510(K) Number
K030813
Device Name
Catheter, Retention Type, Balloon
Applicant
PRIMARY CARE SOLUTIONS, INC.
40420 FREE FALL AVE.
ZEPHYRHILLS, FL 33540 US
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Contact
RON MADDIX
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Regulation Number
876.5130
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Classification Product Code
EZL
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More FDA Info for this Product Code
Date Received
03/14/2003
Decision Date
05/30/2003
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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