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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Encephalogram Telemetry System
510(k) Number K895895
Device Name MODEL 219 TELEMETRY SYSTEM
Applicant
Mennen Medical, Inc.
10123 Main St.
Clarence,  NY  14031
Applicant Contact RICHARD G WHITEHEAD
Correspondent
Mennen Medical, Inc.
10123 Main St.
Clarence,  NY  14031
Correspondent Contact RICHARD G WHITEHEAD
Regulation Number882.1855
Classification Product Code
GYE  
Date Received10/06/1989
Decision Date 02/22/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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