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FDA 510(k) Application Details - K991775
Device Classification Name
Computer, Diagnostic, Pre-Programmed, Single-Function
More FDA Info for this Device
510(K) Number
K991775
Device Name
Computer, Diagnostic, Pre-Programmed, Single-Function
Applicant
MENNEN MEDICAL, INC.
KIRYAT WEIZMANN SCIENCE PARK
P.O. BOX 102
REHOVOT 76100 IL
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Contact
KENNETH RAICHMAN
Other 510(k) Applications for this Contact
Regulation Number
870.1435
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Classification Product Code
DXG
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More FDA Info for this Product Code
Date Received
05/25/1999
Decision Date
06/24/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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