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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
Recalls CDRH Recalls
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