FDA 510(k) Application Details - K061548

Device Classification Name Light, Catheter, Fiberoptic, Glass, Ureteral

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510(K) Number K061548
Device Name Light, Catheter, Fiberoptic, Glass, Ureteral
Applicant STRYKER CORP.
5900 Optical Court
San Jose, CA 95138 US
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Contact ERICA A WALTERS
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Regulation Number 876.4020

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Classification Product Code FCS
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Date Received 06/05/2006
Decision Date 09/28/2006
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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