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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 K852593
Device Name SUNBEAM DENTAL CARE CENTER, MODEL NO. 6273
Applicant
Northern Electric Co. Div. of Sunbeam Corp.
5224 N. Kedzie
Chicago,  IL  60625
Applicant Contact SCHECK
Correspondent
Northern Electric Co. Div. of Sunbeam Corp.
5224 N. Kedzie
Chicago,  IL  60625
Correspondent Contact SCHECK
Regulation Number872.6510
Classification Product Code
EFS  
Date Received06/19/1985
Decision Date 07/24/1985
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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