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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector, Jet, Mechanical-Powered
510(k) Number K864732
Device Name GRADTECH SYRINGE SYSTEM
Applicant
Gradtech
5150 S. Julian Dr.
Suite 204
Tucson,  AZ  85706
Applicant Contact BYRON ECONOMIDY
Correspondent
Gradtech
5150 S. Julian Dr.
Suite 204
Tucson,  AZ  85706
Correspondent Contact BYRON ECONOMIDY
Regulation Number872.4475
Classification Product Code
EGM  
Date Received12/04/1986
Decision Date 04/15/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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