510(k) K905631

COMPRINET, COMTESSE AND BELLAVAR STOCKINGS by Jobst Institute, Inc. — Product Code DWL

K905631 is an FDA 510(k) premarket notification submitted by Jobst Institute, Inc. for the device "COMPRINET, COMTESSE AND BELLAVAR STOCKINGS". The FDA issued a decision of Substantially Equivalent on March 7, 1991. The device falls under product code DWL (Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)), a Class II device regulated under 21 CFR 880.5780. Jobst Institute, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1991
Date Received
December 17, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
Device Class
Class II
Regulation Number
880.5780
Review Panel
HO
Submission Type