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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, percutaneous
510(k) Number K820648
Device Name ARROW M.I.S. MULTI-LUMEN CATHETERIZA
Applicant
ARROW INTL., INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
ARROW INTL., INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number870.1250
Classification Product Code
DQY  
Date Received03/09/1982
Decision Date 04/14/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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