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FDA 510(k) Application Details - K963227
Device Classification Name
Light Source, Endoscope, Xenon Arc
More FDA Info for this Device
510(K) Number
K963227
Device Name
Light Source, Endoscope, Xenon Arc
Applicant
PRODUCTS FOR MEDICINE
52337 AVENIDA NAVARRO
LA QUINTA, CA 92253 US
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Contact
D'ARCY DEEKS
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Regulation Number
876.1500
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Classification Product Code
GCT
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More FDA Info for this Product Code
Date Received
08/19/1996
Decision Date
10/23/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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