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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clip, Scalp
510(k) Number K033660
Device Name STORZ RANEY SCALP CLIP, MODEL 1-20-004-05
Applicant
RUDOLF STORZ GMBH
AMSTEL 320-1
AMSTERDAM,  NL 1017AP
Applicant Contact ANGELIKA SCHERP
Correspondent
RUDOLF STORZ GMBH
AMSTEL 320-1
AMSTERDAM,  NL 1017AP
Correspondent Contact ANGELIKA SCHERP
Regulation Number882.4150
Classification Product Code
HBO  
Date Received11/21/2003
Decision Date 01/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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