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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name media, electroconductive
510(k) Number K780631
Device Name NDM INFANT ECG PACKPAD
Applicant
NEW DIMENSIONS IN MEDICINE, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
NEW DIMENSIONS IN MEDICINE, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.1275
Classification Product Code
GYB  
Date Received04/17/1978
Decision Date 05/03/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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