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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 K161004
Device Name Self-retaining Retractor
Applicant
FETZER MEDICAL GMBH & CO.KG
UNTER BUCHSTEIG 5
Tuttlingen,  DE 78532
Applicant Contact Harald Jung
Correspondent
FETZER MEDICAL GMBH & CO.KG
UNTER BUCHSTEIG 5
Tuttlingen,  DE 78532
Correspondent Contact Harald Jung
Regulation Number882.4800
Classification Product Code
GZT  
Date Received04/11/2016
Decision Date 09/09/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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