FDA 510(k) Application Details - K971734

Device Classification Name Gastroscope And Accessories, Flexible/Rigid

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510(K) Number K971734
Device Name Gastroscope And Accessories, Flexible/Rigid
Applicant WELCH ALLYN, INC.
4341 STATE ST. RD.
P.O. BOX 220
SKANEATELES FALLS, NY 13153-0220 US
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Contact LAWRENCE E MAROCCO
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Regulation Number 876.1500

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Classification Product Code FDS
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Date Received 05/12/1997
Decision Date 07/29/1997
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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