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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rongeur, Manual
510(k) Number K180949
Device Name Steribite
Applicant
Rjr Surgical, Inc.
2530 Superior Ave.
Cleveland,  OH  44114
Applicant Contact John Redmond
Correspondent
Backroads Consulting, Inc.
P.O Box 566
Chesterland,  OH  44026 -0566
Correspondent Contact Karen E. Warden
Regulation Number882.4840
Classification Product Code
HAE  
Date Received04/11/2018
Decision Date 11/08/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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