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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Umbilical Artery
510(k) Number K771022
Device Name CATHETER, UMBILICAR ARTERY
Applicant
Axiom Medical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Axiom Medical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5200
Classification Product Code
FOS  
Date Received06/06/1977
Decision Date 11/29/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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