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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K904482
Device Name STAT.BR TM
Applicant
Kerr Corporation (Danbury)
28200 Wick Rd.
P.O. Box 455
Romulus,  MI  48174
Applicant Contact BENJAMIN WEAVER
Correspondent
Kerr Corporation (Danbury)
28200 Wick Rd.
P.O. Box 455
Romulus,  MI  48174
Correspondent Contact BENJAMIN WEAVER
Regulation Number872.3660
Classification Product Code
ELW  
Date Received10/02/1990
Decision Date 11/29/1990
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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