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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Guard, Disk
510(k) Number K854467
Device Name S.T.P.B SOFT TISSUES PROTECTIVES BLADES
Applicant
Nortex USA, Inc.
1032 31st. St. NW
Washington,  DC  20007
Applicant Contact ANTOINE CHAMBORD
Correspondent
Nortex USA, Inc.
1032 31st. St. NW
Washington,  DC  20007
Correspondent Contact ANTOINE CHAMBORD
Regulation Number872.6010
Classification Product Code
EEJ  
Date Received11/06/1985
Decision Date 03/12/1986
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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