510(k) K960917

PERCUGLIDE by Scientific Device Manufacturer, LLC — Product Code DRE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1996
Date Received
March 6, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Vessel, For Percutaneous Catheterization
Device Class
Class II
Regulation Number
870.1310
Review Panel
CV
Submission Type