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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collimator, Dermatological, Therapeutic X-Ray
510(k) Number K841359
Device Name FENESTRA HOOK
Applicant
Treace Medical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Treace Medical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number892.5900
Classification Product Code
IYL  
Date Received04/02/1984
Decision Date 07/18/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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