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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K910155
Device Name SCIMED OPTAMUM OPER PERIPHERAL ANGIOPLASTY CATH
Applicant
Scimed Life Systems, Inc.
2905 Northwest Blvd., Suite 60
Plymouth,  MN  55441
Applicant Contact DAVID A TEICHER
Correspondent
Scimed Life Systems, Inc.
2905 Northwest Blvd., Suite 60
Plymouth,  MN  55441
Correspondent Contact DAVID A TEICHER
Regulation Number870.1250
Classification Product Code
LIT  
Date Received01/14/1991
Decision Date 02/07/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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