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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 K093054
Device Name SCALP DURA RETRACTOR, MODEL KS00474
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
2151 E. GRAND AVE.
EL SEGUNDO,  CA  90245
Applicant Contact CRYSTAL DIZOL
Correspondent
KARL STORZ ENDOSCOPY-AMERICA, INC.
2151 E. GRAND AVE.
EL SEGUNDO,  CA  90245
Correspondent Contact CRYSTAL DIZOL
Regulation Number882.4800
Classification Product Code
GZT  
Date Received09/30/2009
Decision Date 11/15/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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