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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 K022206
Device Name JENSEN GOLD FOIL
Applicant
Jensen Industries, Inc.
50 Stillman Rd.
North Haven,  CT  06473
Applicant Contact JOHN SLANSKI
Correspondent
Jensen Industries, Inc.
50 Stillman Rd.
North Haven,  CT  06473
Correspondent Contact JOHN SLANSKI
Regulation Number872.3060
Classification Product Code
EJT  
Date Received07/05/2002
Decision Date 08/29/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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