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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Film, X-Ray
510(k) Number K890355
Device Name DENTAL X-RAY BITE BLOCK
Applicant
Bite-A-Block
P.O. Box 810
Daly City,  CA  94017
Applicant Contact NANCY T PUA
Correspondent
Bite-A-Block
P.O. Box 810
Daly City,  CA  94017
Correspondent Contact NANCY T PUA
Regulation Number872.1905
Classification Product Code
EGZ  
Date Received01/24/1989
Decision Date 06/12/1989
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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