510(k) K003828

VASO PRESS DVT FOOT GARMENT #VP 520 by Britt Corp., Inc. — Product Code JOW

K003828 is an FDA 510(k) premarket notification submitted by Britt Corp., Inc. for the device "VASO PRESS DVT FOOT GARMENT #VP 520". The FDA issued a decision of Substantially Equivalent on May 18, 2001. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Britt Corp., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2001
Date Received
December 11, 2000
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