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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, Calcium
510(k) Number K904726
Device Name LYTENING TM 6/R
Applicant
Amdev, Inc.
35 Cherry Hill Dr.
Danvers,  MA  01923
Applicant Contact CONNIE J HERTEL
Correspondent
Amdev, Inc.
35 Cherry Hill Dr.
Danvers,  MA  01923
Correspondent Contact CONNIE J HERTEL
Regulation Number862.1145
Classification Product Code
JFP  
Date Received10/17/1990
Decision Date 12/18/1990
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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