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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K925804
Device Name SCHNEIDER HYDRO-SIL GUIDEWIRE
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 Number870.1330
Classification Product Code
DQX  
Date Received11/16/1992
Decision Date 02/12/1993
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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