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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K970104
Device Name SANI-SHIELD
Applicant
Dw Industries, Inc.
601 13th St. NW
Suite 500 N.
Washington,  DC  20005
Applicant Contact TERRY G MAHN
Correspondent
Dw Industries, Inc.
601 13th St. NW
Suite 500 N.
Washington,  DC  20005
Correspondent Contact TERRY G MAHN
Regulation Number872.4200
Classification Product Code
EFB  
Date Received01/13/1997
Decision Date 05/06/1997
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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