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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ion Specific, Sodium
510(k) Number K870183
Device Name IONOMETER EF AND ACCESSORIES
Applicant
SMASH ENT., INC.
5871 OXFORD ST.
SHOREVIEW,  MN  55125
Applicant Contact STEVEN V BUSH
Correspondent
SMASH ENT., INC.
5871 OXFORD ST.
SHOREVIEW,  MN  55125
Correspondent Contact STEVEN V BUSH
Regulation Number862.1665
Classification Product Code
JGS  
Date Received01/16/1987
Decision Date 05/12/1987
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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