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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Embolectomy
510(k) Number K972572
Device Name SINGLE LUMEN EMBOLECTOMY CATHETER
Applicant
American Biomed, Inc.
11874 S. Evelyn Circle
Houston,  TX  77071 -3404
Applicant Contact J.HARVEY KNAUSS
Correspondent
American Biomed, Inc.
11874 S. Evelyn Circle
Houston,  TX  77071 -3404
Correspondent Contact J.HARVEY KNAUSS
Regulation Number870.5150
Classification Product Code
DXE  
Date Received07/10/1997
Decision Date 01/13/1998
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
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