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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K160811
FOIA Releasable 510(k) K160811
Device Name CRW STEREOTACTIC SYSTEM
Applicant
Integra LifeSciences Corporation
311 Enterprise Dr.
Planisboro,  NJ  08536
Applicant Contact TIMOTHY CONNORS
Correspondent
Integra LifeSciences Corporation
311 Enterprise Dr.
Planisboro,  NJ  08536
Correspondent Contact TIMOTHY CONNORS
Regulation Number882.4560
Classification Product Code
HAW  
Date Received03/24/2016
Decision Date 12/06/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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