510(k) K100909

REPROCESSED COMPRESSION SLEEVES by Ascent Healthcare Solutions — Product Code JOW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2010
Date Received
April 1, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sleeve, Limb, Compressible
Device Class
Class II
Regulation Number
870.5800
Review Panel
CV
Submission Type