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FDA 510(k) Application Details - K971512
Device Classification Name
Electrode, Electrosurgical, Active, Urological
More FDA Info for this Device
510(K) Number
K971512
Device Name
Electrode, Electrosurgical, Active, Urological
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
10700 BREN RD., WEST
MINNETONKA, MN 55343 US
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Contact
JOHN M OTTO
Other 510(k) Applications for this Contact
Regulation Number
876.4300
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Classification Product Code
FAS
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More FDA Info for this Product Code
Date Received
04/28/1997
Decision Date
07/24/1997
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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