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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 K983374
Device Name AGATHA-A-H2010
Applicant
Midian Intl.
5821 NW 28th St.
Lauderhill,  FL  33313
Applicant Contact CHRIS MONTALBANO
Correspondent
Midian Intl.
5821 NW 28th St.
Lauderhill,  FL  33313
Correspondent Contact CHRIS MONTALBANO
Regulation Number872.6510
Classification Product Code
EFS  
Date Received09/25/1998
Decision Date 12/23/1998
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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