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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Primary
510(k) Number K032608
Device Name GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER
Applicant
Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB
Schoenhauser Strasse 73c
Berlin,  DE 13158
Applicant Contact THOMAS BOCK
Correspondent
Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB
Schoenhauser Strasse 73c
Berlin,  DE 13158
Correspondent Contact THOMAS BOCK
Regulation Number862.1150
Classification Product Code
JIS  
Date Received08/25/2003
Decision Date 10/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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