510(k) K012979

COMPRESSIBLE LIMB SLEEVE by Medical Device Services, Inc. — Product Code JOW

K012979 is an FDA 510(k) premarket notification submitted by Medical Device Services, Inc. for the device "COMPRESSIBLE LIMB SLEEVE". The FDA issued a decision of Substantially Equivalent on May 8, 2002. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Medical Device Services, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2002
Date Received
September 5, 2001
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