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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Cartridge
510(k) Number K022959
Device Name SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1
Applicant
MDC Research , Ltd.
21911 Erie Ln.
Lake Forest,  CA  92630
Applicant Contact CAROL PATTERSON
Correspondent
MDC Research , Ltd.
21911 Erie Ln.
Lake Forest,  CA  92630
Correspondent Contact CAROL PATTERSON
Regulation Number872.6770
Classification Product Code
EJI  
Date Received09/06/2002
Decision Date 02/05/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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