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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 K082267
Device Name PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1
Applicant
SMITH & NEPHEW, INC.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Applicant Contact RISHI SINHA
Correspondent
SMITH & NEPHEW, INC.
1450 BROOKS RD.
MEMPHIS,  TN  38116
Correspondent Contact RISHI SINHA
Regulation Number882.4560
Classification Product Code
HAW  
Date Received08/11/2008
Decision Date 10/29/2008
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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