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FDA 510(k) Application Details - K113679
Device Classification Name
Led Light Source
More FDA Info for this Device
510(K) Number
K113679
Device Name
Led Light Source
Applicant
MAQUET SAS
45 BARBOUR POND DRIVE
WAYNE, NJ 07470 US
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Contact
WHITNEY TORNING
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Regulation Number
876.1500
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Classification Product Code
NTN
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More FDA Info for this Product Code
Date Received
12/14/2011
Decision Date
01/12/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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