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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Articulators
510(k) Number K863009
Device Name GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEX
Applicant
Sds Dental, Inc.
4321 Wisconsin Ave. N.W
Suite 200
Washington,  DC  20016
Applicant Contact CESAR CORAL
Correspondent
Sds Dental, Inc.
4321 Wisconsin Ave. N.W
Suite 200
Washington,  DC  20016
Correspondent Contact CESAR CORAL
Regulation Number872.3150
Classification Product Code
EJP  
Date Received08/08/1986
Decision Date 09/25/1986
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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