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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Oral Irrigation
510(k) Number K923711
Device Name PERIOFLEX TIP
Applicant
Novadent, Ltd.
P.O. Box 45127
Jerusalem,  IL 91450
Applicant Contact ELI M ORBACH
Correspondent
Novadent, Ltd.
P.O. Box 45127
Jerusalem,  IL 91450
Correspondent Contact ELI M ORBACH
Regulation Number872.6510
Classification Product Code
EFS  
Date Received07/27/1992
Decision Date 05/16/1994
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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