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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
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