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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector, Jet, Mechanical-Powered
510(k) Number K904279
Device Name PAROJECT ANESTHETIC SYRINGE
Applicant
Ronvig Instruments, Ltd.
18 Lexington Dr.
Milford,  DE  19963
Applicant Contact DANIEL PARRILLI
Correspondent
Ronvig Instruments, Ltd.
18 Lexington Dr.
Milford,  DE  19963
Correspondent Contact DANIEL PARRILLI
Regulation Number872.4475
Classification Product Code
EGM  
Date Received09/17/1990
Decision Date 12/07/1990
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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