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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 K902091
Device Name SCHNEIDER MONORAIL(TM) SOFTRAC-PTA(TM) CATHETER
Applicant
Schneider Intl., Ltd.
5905 Nathan Ln.
Plymouth,  MN  55442
Applicant Contact ROBERT L ULLEN
Correspondent
Schneider Intl., Ltd.
5905 Nathan Ln.
Plymouth,  MN  55442
Correspondent Contact ROBERT L ULLEN
Regulation Number870.1250
Classification Product Code
LIT  
Date Received05/09/1990
Decision Date 09/26/1990
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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