510(k) K143166

Medline ReNewal Reprocessed Compression Limb Sleeves by Surgical Instrument Service and Savings (Dba Medline Renewal — Product Code JOW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2015
Date Received
November 4, 2014
Clearance Type
Special
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