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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Pre-Programmed, Single-Function
510(k) Number K896528
Device Name SFA MODULE
Applicant
LIFE SCIENCES MANUFACTURING, INC.
AIRPORT INDUSTRIAL PARK
BOX 37F
WEST LEBANON,  NH  03784
Applicant Contact ROBERT S CUTLER
Correspondent
LIFE SCIENCES MANUFACTURING, INC.
AIRPORT INDUSTRIAL PARK
BOX 37F
WEST LEBANON,  NH  03784
Correspondent Contact ROBERT S CUTLER
Regulation Number870.1435
Classification Product Code
DXG  
Date Received11/16/1989
Decision Date 01/26/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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