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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Nasal
510(k) Number K882131
Device Name NOSE BRACE
Applicant
Allied Advanced Technologies (Aat)
600 Enterprise Dr.
Suite 214a
Oak Brook,  IL  60521
Applicant Contact REZAKHANY, PHD
Correspondent
Allied Advanced Technologies (Aat)
600 Enterprise Dr.
Suite 214a
Oak Brook,  IL  60521
Correspondent Contact REZAKHANY, PHD
Regulation Number874.3900
Classification Product Code
LWF  
Date Received05/20/1988
Decision Date 07/15/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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