510(k) K812621

DELTA-A.V. FISTULA CANNULATION SET by Amisco Trading Corp. — Product Code FIE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1981
Date Received
September 15, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Fistula
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type