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FDA 510(k) Application Details - K971734
Device Classification Name
Gastroscope And Accessories, Flexible/Rigid
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
FDS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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