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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 K951738
Device Name ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER
Applicant
Sherwood Medical Co.
1915 Olive St.
St. Louis,  MO  63103 -1625
Applicant Contact DENNIS POZZO
Correspondent
Sherwood Medical Co.
1915 Olive St.
St. Louis,  MO  63103 -1625
Correspondent Contact DENNIS POZZO
Regulation Number880.5200
Classification Product Code
FOS  
Date Received04/14/1995
Decision Date 09/29/1995
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
Recalls CDRH Recalls
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