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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 K924645
Device Name TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS
Applicant
Unitek Corp.
2724 S. Peck Rd.
Monrovia,  CA  91016 -5097
Applicant Contact MARLYN SCHEFF
Correspondent
Unitek Corp.
2724 S. Peck Rd.
Monrovia,  CA  91016 -5097
Correspondent Contact MARLYN SCHEFF
Regulation Number872.4565
Classification Product Code
JEX  
Date Received09/14/1992
Decision Date 11/25/1992
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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