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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Headgear, Extraoral, Orthodontic
510(k) Number K936151
Device Name EXTRAORAL HEADGEAR
Applicant
Dentauraum, Inc.
10 Pheasant Run
Newtown,  PA  18940
Applicant Contact JOHN J ROTH, JR.
Correspondent
Dentauraum, Inc.
10 Pheasant Run
Newtown,  PA  18940
Correspondent Contact JOHN J ROTH, JR.
Regulation Number872.5500
Classification Product Code
DZB  
Date Received12/27/1993
Decision Date 08/01/1994
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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