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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
Predetermined Change
Control Plan Authorized		 No
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