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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implantable Pacemaker Pulse-Generator
510(k) Number K920157
Device Name SCHNEIDER 8 FR. STAMINA(TM) GUIDING 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 Number870.3610
Classification Product Code
DXY  
Date Received01/14/1992
Decision Date 03/16/1992
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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