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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Subclavian
510(k) Number K822134
Device Name SHIELY DUEL LUMEN SUBCLAVIAN CANNULA
Applicant
Shiley, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Shiley, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.5540
Classification Product Code
LFJ  
Date Received07/20/1982
Decision Date 08/03/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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