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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clasp, Preformed
510(k) Number K954971
Device Name ACETAL DENTAL/PREFORMED CLASP
Applicant
B & H Technical Services , Ltd.
2020 124th Ave., NE
Suite C-106
Bellevue,  WA  98005
Applicant Contact RAYMOND CHINEA
Correspondent
B & H Technical Services , Ltd.
2020 124th Ave., NE
Suite C-106
Bellevue,  WA  98005
Correspondent Contact RAYMOND CHINEA
Regulation Number872.3285
Classification Product Code
EHP  
Date Received10/27/1995
Decision Date 12/11/1995
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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