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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Maintainer, Space Preformed, Orthodontic
510(k) Number K780814
Device Name SAFETY STOP NECKSTRAP
Applicant
Northwest Orthodontics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Northwest Orthodontics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.5525
Classification Product Code
DYT  
Date Received05/18/1978
Decision Date 06/30/1978
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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