Cleared Special

BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)

K131496 · Bsn Medical, Inc. · General Hospital

Jul 2013

Decision

48d

Days

Class 2

Risk

About This 510(k) Submission

K131496 is an FDA 510(k) clearance for the BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE), a Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) (Class II — Special Controls, product code DWL), submitted by Bsn Medical, Inc. (Rutherford College, US). The FDA issued a Cleared decision on July 10, 2013, 48 days after receiving the submission on May 23, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5780.

Submission Details

510(k) Number	K131496 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 23, 2013
Decision Date	July 10, 2013
Days to Decision	48 days
Submission Type	Special
Review Panel	General Hospital (HO)
Summary	Statement

Device Classification

Product Code	DWL — Stocking, Medical Support (to Prevent Pooling Of Blood In Legs)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5780