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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Display, Cathode-Ray Tube, Medical
510(k) Number K770279
Device Name MONITOR, PORTABLE, PART #431-010
Applicant
Mennen Greatbatch Electonics
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Mennen Greatbatch Electonics
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.2450
Classification Product Code
DXJ  
Date Received02/14/1977
Decision Date 02/24/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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