510(k) K051227

RENU MEDICAL REPROCESSED ALP 1 CALF GARMENT, MODEL ALP1 by Renu Medical, Inc. — Product Code JOW

K051227 is an FDA 510(k) premarket notification submitted by Renu Medical, Inc. for the device "RENU MEDICAL REPROCESSED ALP 1 CALF GARMENT, MODEL ALP1". The FDA issued a decision of Substantially Equivalent on April 7, 2006. 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
April 7, 2006
Date Received
May 12, 2005
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