510(k) K031559

RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES by Renu Medical, Inc. — Product Code JOW

K031559 is an FDA 510(k) premarket notification submitted by Renu Medical, Inc. for the device "RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES". The FDA issued a decision of Substantially Equivalent on November 12, 2003. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Renu Medical, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 2003
Date Received
May 19, 2003
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