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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 K964737
Device Name HYDROPREP GEL
Applicant
D.O. Weaver Co.
565-C Nucla Way
Aurora,  CO  80011
Applicant Contact DAVID O WEAVER
Correspondent
D.O. Weaver Co.
565-C Nucla Way
Aurora,  CO  80011
Correspondent Contact DAVID O WEAVER
Regulation Number882.1275
Classification Product Code
GYB  
Date Received11/25/1996
Decision Date 03/19/1997
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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