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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 K852956
Device Name CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION
Applicant
Parker Laboratories, Inc.
307 Washington St.
Orange,  NJ  07050
Applicant Contact MARTIN BUCHALTER
Correspondent
Parker Laboratories, Inc.
307 Washington St.
Orange,  NJ  07050
Correspondent Contact MARTIN BUCHALTER
Regulation Number882.1275
Classification Product Code
GYB  
Date Received07/11/1985
Decision Date 08/09/1985
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
Recalls CDRH Recalls
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