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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tape, measuring, rulers and calipers
510(k) Number K160501
Device Name Noxilizer Surgical Ruler
Applicant
Noxilizer,Inc.
800 West Baltimore Street
Suite 151
Baltimore,  MD  21201
Applicant Contact Mary Dadone
Correspondent
Noxilizer,Inc.
800 West Baltimore Street
Suite 151
Baltimore,  MD  21201
Correspondent Contact Mary Dadone
Regulation Number878.4800
Classification Product Code
FTY  
Subsequent Product Code
FZZ  
Date Received02/23/2016
Decision Date 05/26/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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