FDA 510(k) Application Details - K011848

Device Classification Name Lithotriptor, Electro-Hydraulic

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510(K) Number K011848
Device Name Lithotriptor, Electro-Hydraulic
Applicant CIRCON VIDEO
6500 HOLLISTER AVE.
SANTA BARBARA, CA 93117-3019 US
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Contact JERRY CROUTHERS
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Regulation Number 876.4480

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Classification Product Code FFK
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Date Received 06/13/2001
Decision Date 09/11/2001
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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