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FDA 510(k) Application Details - K130908
Device Classification Name
Catheter, Retention Type, Balloon
More FDA Info for this Device
510(K) Number
K130908
Device Name
Catheter, Retention Type, Balloon
Applicant
GUANGDONG BAIHE MEDICAL TECHNOLOGY CO., LTD
PO BOX 120-119
SHANGHAI 200120 CN
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Contact
Diana Hong
Other 510(k) Applications for this Contact
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
04/01/2013
Decision Date
10/03/2013
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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