510(k) K143317

Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes) by Currie Medical Specialties, Inc. — Product Code JOW

K143317 is an FDA 510(k) premarket notification submitted by Currie Medical Specialties, Inc. for the device "Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes)". The FDA issued a decision of Substantially Equivalent on January 20, 2015. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Currie Medical Specialties, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 2015
Date Received
November 19, 2014
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