FDA 510(k) Application Details - K963227

Device Classification Name Light Source, Endoscope, Xenon Arc

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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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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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