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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clasp, Wire
510(k) Number K872746
Device Name VITALLIUM WIRE
Applicant
Austenal Dental, Inc.
5101 S. Keeler Ave.
Chicago,  IL  60632
Applicant Contact GILBERT K NTOW
Correspondent
Austenal Dental, Inc.
5101 S. Keeler Ave.
Chicago,  IL  60632
Correspondent Contact GILBERT K NTOW
Regulation Number872.3285
Classification Product Code
EJW  
Date Received07/13/1987
Decision Date 07/21/1987
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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