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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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