FDA 510(k) Application Details - K961762

Device Classification Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

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510(K) Number K961762
Device Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Applicant UNITED STATES ENDOSCOPY GROUP, INC.
9330 PROGRESS PKWY.
MENTOR, OH 44060 US
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Contact GRETCHEN YOUNKER
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Regulation Number 876.4300

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Classification Product Code KNS
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Date Received 05/07/1996
Decision Date 07/22/1996
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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