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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 K944600
Device Name GRAHAM-FIELD SALINE ELECTROLYTE GEL
Applicant
Chester Labs, Inc.
3208 Dixie Hwy.
Erlanger,  KY  41018
Applicant Contact VERA PRACHT
Correspondent
Chester Labs, Inc.
3208 Dixie Hwy.
Erlanger,  KY  41018
Correspondent Contact VERA PRACHT
Regulation Number882.1275
Classification Product Code
GYB  
Date Received09/19/1994
Decision Date 11/20/1995
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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