FDA 510(k) Application Details - K012265

Device Classification Name Light Source, Fiberoptic, Routine

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510(K) Number K012265
Device Name Light Source, Fiberoptic, Routine
Applicant CIRCON VIDEO
6500 HOLLISTER AVE.
SANTA BARBARA, CA 93117-3019 US
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Contact WAYNE B STERNER
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Regulation Number 876.1500

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Classification Product Code FCW
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Date Received 07/19/2001
Decision Date 10/17/2001
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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