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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 K023232
Device Name SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE
Applicant
Smartpractice
3400 E. Mcdowell Rd.
Phoenix,  AZ  85008
Applicant Contact KIM SULLIVAN
Correspondent
Smartpractice
3400 E. Mcdowell Rd.
Phoenix,  AZ  85008
Correspondent Contact KIM SULLIVAN
Regulation Number872.6510
Classification Product Code
EFS  
Date Received09/27/2002
Decision Date 12/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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