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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retractor, Self-Retaining, For Neurosurgery
510(k) Number K112913
Device Name SPOTLIGHT ACCESS SYSTEM
Applicant
Johnson & Johnson
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact LAURA BLEYENDAAL
Correspondent
Johnson & Johnson
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact LAURA BLEYENDAAL
Regulation Number882.4800
Classification Product Code
GZT  
Date Received10/03/2011
Decision Date 12/16/2011
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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