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FDA 510(k) Application Details - K991426
Device Classification Name
Resectoscope, Working Element
More FDA Info for this Device
510(K) Number
K991426
Device Name
Resectoscope, Working Element
Applicant
MAHE INTL., INC.
300 JAMES ROBERTSON PKWY.
NASHVILLE, TN 37201 US
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Contact
WINIFRIED REICH
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
FDC
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More FDA Info for this Product Code
Date Received
04/23/1999
Decision Date
08/05/1999
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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