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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plier, Orthodontic
510(k) Number K843742
Device Name UNITEK CONVERTIBLE CAP REMOVER TOOL
Applicant
Unitek Corp.
2724 S. Peck Rd.
Monrovia,  CA  91016
Applicant Contact LAWRENCE STEVENS
Correspondent
Unitek Corp.
2724 S. Peck Rd.
Monrovia,  CA  91016
Correspondent Contact LAWRENCE STEVENS
Regulation Number872.4565
Classification Product Code
JEX  
Date Received09/25/1984
Decision Date 11/09/1984
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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