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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 K853832
Device Name LYTENING 1
Applicant
Amdev, Inc.
40 Rogers Rd.
Wall Hill Industrial Park
Haverhill,  MA  01830
Applicant Contact DONALD SCHWARTZ
Correspondent
Amdev, Inc.
40 Rogers Rd.
Wall Hill Industrial Park
Haverhill,  MA  01830
Correspondent Contact DONALD SCHWARTZ
Regulation Number862.1665
Classification Product Code
JGS  
Date Received09/13/1985
Decision Date 10/04/1985
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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