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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 K061904
Device Name COMPUDENT STA
Applicant
Milestone Scientific, Inc.
5335 Wisconsin Ave. NW
Suite 440
Washington,  DC  20015
Applicant Contact DANIEL J MANELLI
Correspondent
Milestone Scientific, Inc.
5335 Wisconsin Ave. NW
Suite 440
Washington,  DC  20015
Correspondent Contact DANIEL J MANELLI
Regulation Number872.6770
Classification Product Code
EJI  
Date Received07/05/2006
Decision Date 08/08/2006
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
Recalls CDRH Recalls
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