FDA 510(k) Application Details - K962676

Device Classification Name Dislodger, Stone, Flexible

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510(K) Number K962676
Device Name Dislodger, Stone, Flexible
Applicant UNITED STATES ENDOSCOPY GROUP, INC.
9330 PROGRESS PKWY.
MENTOR, OH 44060 US
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Contact DEAN SECREST
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Regulation Number 876.4680

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Classification Product Code FGO
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Date Received 07/09/1996
Decision Date 10/04/1996
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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