510(k) K101330

MIDWEST REPROCESSING CENTER REPROCESSED SCD EXPRESS SLEEVES/ FOOT CUFFS, MIDWEST REPROCESSING CENTER REPROCESSED ALP SLE by Midwest Reprocessing Center, LLC — Product Code JOW

K101330 is an FDA 510(k) premarket notification submitted by Midwest Reprocessing Center, LLC for the device "MIDWEST REPROCESSING CENTER REPROCESSED SCD EXPRESS SLEEVES/ FOOT CUFFS, MIDWEST REPROCESSING CENTER REPROCESSED ALP SLE". The FDA issued a decision of Substantially Equivalent on August 27, 2010. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Midwest Reprocessing Center, LLC has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2010
Date Received
May 12, 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