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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 K926121
Device Name BRASS NICK IMPRES TRAY/AMALGAM CAR/SYRIN CART/ARTI
Applicant
Dentmed , Ltd.
4936-C Eisenhower Ave.
Alexandria,  VA  22304
Applicant Contact TABUSUM
Correspondent
Dentmed , Ltd.
4936-C Eisenhower Ave.
Alexandria,  VA  22304
Correspondent Contact TABUSUM
Regulation Number872.6770
Classification Product Code
EJI  
Date Received12/03/1992
Decision Date 02/03/1994
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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