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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 K854088
Device Name UNITEK LIFT-OFF DEBRACKETING INSTRUMENT
Applicant
Unitex Corp.
2724 S. Peck Rd.
Monrovia,  CA  91016
Applicant Contact LAWRENCE STEVENS
Correspondent
Unitex Corp.
2724 S. Peck Rd.
Monrovia,  CA  91016
Correspondent Contact LAWRENCE STEVENS
Regulation Number872.4565
Classification Product Code
JEX  
Date Received10/07/1985
Decision Date 11/26/1985
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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