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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 K904527
Device Name KAPPER
Original Applicant
1118 e adams ave.
orange,  CA  92667
Original Contact richard g deniro
Regulation Number872.6770
Classification Product Code
Date Received10/02/1990
Decision Date 12/21/1990
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No