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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bracket, metal, orthodontic
510(k) Number K930452
Device Name SOLO TIES
Applicant
ZULAF, INC.
P.O. BOX 6661
LUBBUCK,  TX  79493
Applicant Contact RUTLEDGE REYNOLDS
Correspondent
ZULAF, INC.
P.O. BOX 6661
LUBBUCK,  TX  79493
Correspondent Contact RUTLEDGE REYNOLDS
Regulation Number872.5410
Classification Product Code
EJF  
Date Received01/27/1993
Decision Date 07/08/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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