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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Pick, Massaging
510(k) Number K883225
Device Name FLOSSIE
Applicant
Richard G. Deniro
1500 E. Katella Ave.,
Suite K
Orange,  CA  92667
Correspondent
Richard G. Deniro
1500 E. Katella Ave.,
Suite K
Orange,  CA  92667
Regulation Number872.6650
Classification Product Code
JET  
Date Received08/01/1988
Decision Date 08/30/1988
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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