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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 K923218
Device Name NITANIUM PALATAL EXPANDER
Applicant
Ortho Organizers, Inc.
1619 S. Rancho Santa Fe Rd.
San Marcos,  CA  92069
Applicant Contact CARL BERNDT
Correspondent
Ortho Organizers, Inc.
1619 S. Rancho Santa Fe Rd.
San Marcos,  CA  92069
Correspondent Contact CARL BERNDT
Regulation Number872.5410
Classification Product Code
EJF  
Date Received07/01/1992
Decision Date 09/13/1993
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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