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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 K821684
Device Name MCSCP8PS WITH 'Y' HUB
Applicant
Medical Components, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Medical Components, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.5540
Classification Product Code
LFJ  
Date Received06/08/1982
Decision Date 06/24/1982
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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