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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K100833
Device Name SYLE SMARTIP
Applicant
Osspray, Ltd.
3116 NW 62nd Ter.
Gainesville,  FL  32606
Applicant Contact DAVID GREENSPAN
Correspondent
Osspray, Ltd.
3116 NW 62nd Ter.
Gainesville,  FL  32606
Correspondent Contact DAVID GREENSPAN
Regulation Number872.4200
Classification Product Code
EFB  
Subsequent Product Code
EJR  
Date Received03/24/2010
Decision Date 06/03/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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