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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 K090272
Device Name SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES)
Applicant
Cardinal Health, Inc.
1430 Waukegan Rd.- Mpkb-2b
Mcgaw Park,  IL  60085
Applicant Contact GINA RAJTEROWSKI
Correspondent
Cardinal Health, Inc.
1430 Waukegan Rd.- Mpkb-2b
Mcgaw Park,  IL  60085
Correspondent Contact GINA RAJTEROWSKI
Regulation Number882.4800
Classification Product Code
GZT  
Date Received02/04/2009
Decision Date 03/18/2009
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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