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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bracket, Plastic, Orthodontic
510(k) Number K900809
Device Name LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETS
Applicant
Lee Pharmaceuticals
1444 Santa Anita
P.O. Box 3836
South El Monte,  CA  91733
Applicant Contact LEE, PH.D.
Correspondent
Lee Pharmaceuticals
1444 Santa Anita
P.O. Box 3836
South El Monte,  CA  91733
Correspondent Contact LEE, PH.D.
Regulation Number872.5470
Classification Product Code
DYW  
Date Received02/21/1990
Decision Date 06/28/1990
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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