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510(k) K981630

VYGON DOUBLE LUMEN UMBILICAL CATHETER by Schiff & Co. — Product Code FOS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 1998
Date Received
May 7, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Umbilical Artery
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

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