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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 K911196
Device Name SCHNEIDER TOTAL CROSS .021 PERCU TRANS ANGIO (PTA)
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 Received03/18/1991
Decision Date 06/10/1991
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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