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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Meter, Conductivity, Non-Remote
510(k) Number K981294
Device Name ODYSSEY INSTRUMENTATION SYSTEM
Applicant
Automata Instrumentation, Inc.
15600 N. 78th St.
Scottsdale,  AZ  85260 -1735
Applicant Contact LINDA V MASANO
Correspondent
Automata Instrumentation, Inc.
15600 N. 78th St.
Scottsdale,  AZ  85260 -1735
Correspondent Contact LINDA V MASANO
Regulation Number876.5820
Classification Product Code
FIZ  
Date Received04/09/1998
Decision Date 07/08/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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