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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 K150428
Device Name Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs
Applicant
Integra Lifesciences Corp.
311 Enterprise Dr.
Planisboro,  NJ  08536
Applicant Contact Judith E O'Grady
Correspondent
Integra LifeSciences Corporation
589 Davies Dr.
York,  PA  17402
Correspondent Contact Stephanie N Sheesley
Regulation Number882.4840
Classification Product Code
HAE  
Date Received02/19/2015
Decision Date 04/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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