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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 K002168
Device Name ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE
Applicant
Ronvig Instruments, Ltd.
Gl.Vejlevej 57-59
Dk-8721 Daugaard,  DK DK-8721
Applicant Contact ANNETTE RAVN NEILSEN
Correspondent
Ronvig Instruments, Ltd.
Gl.Vejlevej 57-59
Dk-8721 Daugaard,  DK DK-8721
Correspondent Contact ANNETTE RAVN NEILSEN
Regulation Number872.6770
Classification Product Code
EJI  
Date Received07/17/2000
Decision Date 10/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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