FDA 510(k) Application Details - K972505

Device Classification Name Forceps, Biopsy, Electric

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510(K) Number K972505
Device Name Forceps, Biopsy, Electric
Applicant UNITED STATES ENDOSCOPY GROUP, INC.
9330 PROGRESS PKWY.
MENTOR, OH 44060 US
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Contact GRETCHEN Y COHEN
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Regulation Number 876.4300

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Classification Product Code KGE
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Date Received 07/03/1997
Decision Date 09/18/1997
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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