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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.
PLAINSBORO,  NJ  08536
Applicant Contact Judith E O'Grady
Correspondent
INTEGRA LIFESCIENCES CORPORATION
589 DAVIES DRIVE
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
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