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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 K813378
Device Name UNI-BITE DENTAL X-RAY FILM HOLDER
Applicant
Rinn Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Rinn Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.1905
Classification Product Code
EGZ  
Date Received12/01/1981
Decision Date 01/29/1982
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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