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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 K120659
Device Name HU-FRIEDY DENTAL CARTRIDGE SYRINGE
Applicant
Hu-Friedy Mfg. Co., LLC
3232 N Rockwell St.
Chicago,  IL  60618
Applicant Contact MARIA VRABIE
Correspondent
Hu-Friedy Mfg. Co., LLC
3232 N Rockwell St.
Chicago,  IL  60618
Correspondent Contact MARIA VRABIE
Regulation Number872.6770
Classification Product Code
EJI  
Date Received03/05/2012
Decision Date 11/06/2012
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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