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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Osmometer For Clinical Use
510(k) Number K925970
Device Name MODEL 3D3 OSMOMETER
Applicant
ADVANCED INSTRUMENTS, INC.
TOW TECHNOLOGY WAY
NORWOOD,  MA  02062
Applicant Contact DOUGLAS GUERETTE
Correspondent
ADVANCED INSTRUMENTS, INC.
TOW TECHNOLOGY WAY
NORWOOD,  MA  02062
Correspondent Contact DOUGLAS GUERETTE
Regulation Number862.2730
Classification Product Code
JJM  
Date Received11/25/1992
Decision Date 07/09/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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