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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Gold-Based Noble Metal
510(k) Number K011659
Device Name GPW-SF
Applicant
Gateway Alloys, Inc.
1702 Scherer Pkwy.
St. Charles,  MO  63303
Applicant Contact JOHN C CONSTANTINE
Correspondent
Gateway Alloys, Inc.
1702 Scherer Pkwy.
St. Charles,  MO  63303
Correspondent Contact JOHN C CONSTANTINE
Regulation Number872.3060
Classification Product Code
EJT  
Date Received05/29/2001
Decision Date 08/27/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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