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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Thermodilution
510(k) Number K912172
Device Name SAFEWEDGE(TM) RELIEF VALVE DEVICE
Applicant
Sunscope Intl., Inc.
1775 Shawness Ct.
Westlake Village,  CA  91362
Applicant Contact KEITH CHAN
Correspondent
Sunscope Intl., Inc.
1775 Shawness Ct.
Westlake Village,  CA  91362
Correspondent Contact KEITH CHAN
Regulation Number870.1915
Classification Product Code
KRB  
Date Received05/16/1991
Decision Date 09/27/1991
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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