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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K905011
Device Name ORAL PHARYNGEAL CLEANSING DEVICE
Applicant
Concord/Portex
15 Kitt St.
Keene,  NH  03431
Applicant Contact ROBERT WHEELER
Correspondent
Concord/Portex
15 Kitt St.
Keene,  NH  03431
Correspondent Contact ROBERT WHEELER
Regulation Number872.6640
Classification Product Code
EIA  
Date Received11/07/1990
Decision Date 01/31/1991
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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