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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 K944599
Device Name GRAHAM-FIELD CONDUCTIVE ECG SPRAY
Applicant
CHESTER LABS, INC.
1900 SECTION RD., SUITE A
CINCINNATI,  OH  45237
Applicant Contact HOLLY SHERWOOD
Correspondent
CHESTER LABS, INC.
1900 SECTION RD., SUITE A
CINCINNATI,  OH  45237
Correspondent Contact HOLLY SHERWOOD
Regulation Number882.1275
Classification Product Code
GYB  
Date Received09/19/1994
Decision Date 05/07/1996
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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