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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 K790611
Device Name OSMOMETER MODEL 3W11
Applicant
Advanced Instruments, Inc.
Shorashim
Correspondent
Advanced Instruments, Inc.
Shorashim
Regulation Number862.2730
Classification Product Code
JJM  
Date Received03/29/1979
Decision Date 06/15/1979
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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