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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 K912317
Device Name SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO PTA CATH
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 Received05/24/1991
Decision Date 08/22/1991
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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