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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name amplifier, physiological signal
510(k) Number K943673
Device Name MMC AMPLIFIER
Applicant
MELVILLE SOFTWARE LTD.
350 SPARKS ST.
SUITE 1007
OTTAWA, ONTARIO,  CA K1R 7S8
Applicant Contact Tom Anderson
Correspondent
MELVILLE SOFTWARE LTD.
350 SPARKS ST.
SUITE 1007
OTTAWA, ONTARIO,  CA K1R 7S8
Correspondent Contact Tom Anderson
Regulation Number882.1835
Classification Product Code
GWL  
Date Received07/26/1994
Decision Date 10/26/1994
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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