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510(k) K010197

EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET by Exelint International, Co. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2001
Date Received
January 22, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

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