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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 K931663
Device Name NITANIUM PRO FORM ARCHWIRES,ROUND,SQUARE,RECTANGUL
Applicant
Ortho Organizers, Inc.
1619 S. Rancho Santa Fe Rd.
San Marcos,  CA  92069
Applicant Contact CHUCK TYRRELL
Correspondent
Ortho Organizers, Inc.
1619 S. Rancho Santa Fe Rd.
San Marcos,  CA  92069
Correspondent Contact CHUCK TYRRELL
Regulation Number872.5410
Classification Product Code
EJF  
Date Received04/05/1993
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
Predetermined Change
Control Plan Authorized		 No
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