FDA 510(k) Application Details - K992050

Device Classification Name Light Source, Endoscope, Xenon Arc

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510(K) Number K992050
Device Name Light Source, Endoscope, Xenon Arc
Applicant WALTER LORENZ SURGICAL, INC.
1520 TRADEPORT DR.
JACKSONVILLE, FL 32218-2480 US
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Contact TREVOR BYRD
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Regulation Number 876.1500

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Classification Product Code GCT
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Date Received 06/17/1999
Decision Date 09/14/1999
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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