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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Vascular, For Promoting Embolization
510(k) Number K892446
Device Name SHILEY EQUIPMENT SUPPORT CARTS ESC-002 & ESCB-02
Applicant
Shiley, Inc.
17600 Gillette Ave.
P.O. Box 19503
Irvine,  CA  92714
Applicant Contact LOUIS J MAZZARESE
Correspondent
Shiley, Inc.
17600 Gillette Ave.
P.O. Box 19503
Irvine,  CA  92714
Correspondent Contact LOUIS J MAZZARESE
Regulation Number870.3300
Classification Product Code
KRD  
Date Received04/10/1989
Decision Date 07/14/1989
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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