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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 K010414
Device Name R & D DESIGNATION AP-035
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 Received02/12/2001
Decision Date 03/27/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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