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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name clamp, vascular
510(k) Number K102048
Device Name ATRAUMATIC VASCULAR CLAMPS
Applicant
GEOMED MEDIZIN- TECHNIK GMBH & CO. KG
UNTERER WINKEL 3
WUMLINGEN,  DE 78532
Applicant Contact HARALD JUNG
Correspondent
GEOMED MEDIZIN- TECHNIK GMBH & CO. KG
UNTERER WINKEL 3
WUMLINGEN,  DE 78532
Correspondent Contact HARALD JUNG
Regulation Number870.4450
Classification Product Code
DXC  
Date Received07/21/2010
Decision Date 11/09/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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