510(k) K950200

IVID by Scott/Ross Designs, Inc. — Product Code FPK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1995
Date Received
January 18, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubing, Fluid Delivery
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type