510(k) K924369

ILS(TM) - INVASIVE LINE SEPARATOR by 2-Rn Corp. — Product Code KMK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1993
Date Received
August 28, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Intravascular Catheter Securement
Device Class
Class I
Regulation Number
880.5210
Review Panel
HO
Submission Type