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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 K941349
Device Name DENTAL TRAY
Applicant
Cush Medical Products
881 Mountain View Dr.
Piney Flats,  TN  37686
Applicant Contact STEVE B JOHNSTON
Correspondent
Cush Medical Products
881 Mountain View Dr.
Piney Flats,  TN  37686
Correspondent Contact STEVE B JOHNSTON
Regulation Number872.6640
Classification Product Code
EIA  
Date Received03/21/1994
Decision Date 07/26/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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