510(k) K991038

VASO PRESS DVT SYSTEM, MODELS VP500, VP501 by Britt Corp., Inc. — Product Code JOW

K991038 is an FDA 510(k) premarket notification submitted by Britt Corp., Inc. for the device "VASO PRESS DVT SYSTEM, MODELS VP500, VP501". The FDA issued a decision of Substantially Equivalent on June 22, 2000. 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
June 22, 2000
Date Received
March 29, 1999
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