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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K896741
Device Name SCHNEIDER MONORAIL-PMC PRESSURE MONITORING CATH.
Applicant
Schneider Intl., Ltd.
2905 Northwest Blvd.
Minneapolis,  MN  55441
Applicant Contact HOWARD B WITTELS
Correspondent
Schneider Intl., Ltd.
2905 Northwest Blvd.
Minneapolis,  MN  55441
Correspondent Contact HOWARD B WITTELS
Regulation Number870.1200
Classification Product Code
DQO  
Date Received11/30/1989
Decision Date 02/28/1990
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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