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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
Original Applicant
HU-FRIEDY MFG. CO. LLC
3232 n rockwell street
chicago,  IL  60618
Original 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
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