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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 K964402
Device Name VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM
Applicant
V. Mueller Neuro/Spine
871 Industrial Rd.
San Carlos,  CA  94070
Applicant Contact TERRY JOHNSON
Correspondent
V. Mueller Neuro/Spine
871 Industrial Rd.
San Carlos,  CA  94070
Correspondent Contact TERRY JOHNSON
Regulation Number882.4800
Classification Product Code
GZT  
Date Received11/04/1996
Decision Date 01/23/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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