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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spring, Orthodontic
510(k) Number K942492
Device Name ADJUSTABLE BITE CORRECTOR
Applicant
Orthoplus, Inc.
1275 Fourth St., Suite 381
Santa Rosa,  CA  95404
Applicant Contact DAVID LEE
Correspondent
Orthoplus, Inc.
1275 Fourth St., Suite 381
Santa Rosa,  CA  95404
Correspondent Contact DAVID LEE
Regulation Number872.5410
Classification Product Code
ECO  
Date Received05/25/1994
Decision Date 07/13/1994
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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