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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 K982365
Device Name ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMAT
Applicant
Geister Medizin Technik GmbH
Foehrenstr. 2
Tuttlingen,  DE D-78532
Applicant Contact DAGMAR S MASER
Correspondent
Geister Medizin Technik GmbH
Foehrenstr. 2
Tuttlingen,  DE D-78532
Correspondent Contact DAGMAR S MASER
Regulation Number870.4450
Classification Product Code
DXC  
Date Received07/07/1998
Decision Date 04/08/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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