FDA 510(k) Application Details - K982620

Device Classification Name Cystoscope And Accessories, Flexible/Rigid

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510(K) Number K982620
Device Name Cystoscope And Accessories, Flexible/Rigid
Applicant MEDIVISION SCOPE SERVICE CENTER, INC.
1440 SOUTH STATE COLLEGE BLVD.
SUITE 1C
ANAHEIM, CA 92806 US
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Contact WAYNE B STERNER
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Regulation Number 876.1500

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Classification Product Code FAJ
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Date Received 07/27/1998
Decision Date 09/30/1998
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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