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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
Applicant
Senair-Mot
1118 E Adams Ave.
Orange,  CA  92667
Applicant Contact RICHARD G DENIRO
Correspondent
Senair-Mot
1118 E Adams Ave.
Orange,  CA  92667
Correspondent Contact RICHARD G DENIRO
Regulation Number872.6770
Classification Product Code
EJI  
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
Predetermined Change
Control Plan Authorized		 No
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