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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin
510(k) Number K844133
Device Name CLEANSE N BOND I
Applicant
Lee Pharmaceuticals
1444 Santa Anita
P.O. Box 3836
South El Monte,  CA  91733
Applicant Contact DIAN TEIGLER
Correspondent
Lee Pharmaceuticals
1444 Santa Anita
P.O. Box 3836
South El Monte,  CA  91733
Correspondent Contact DIAN TEIGLER
Regulation Number872.3750
Classification Product Code
DYH  
Date Received10/23/1984
Decision Date 01/04/1985
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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