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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 K802899
Device Name CERAMIBOND
Applicant
ZULAUF, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
ZULAUF, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number872.5470
Classification Product Code
DYW  
Date Received11/17/1980
Decision Date 12/19/1980
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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