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

Device Classification Name

stocking, medical support (to prevent pooling of blood in legs)

510(k) Number K131496
Device Name BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)
Applicant
BSN MEDICAL, INC.
100 beiersdorf drive
rutherford college, 
NC 
28671

Applicant Contact carroll d hoyle
Correspondent
BSN MEDICAL, INC.
100 beiersdorf drive
rutherford college, 
NC 
28671

Correspodent Contact carroll d hoyle
Regulation Number 880.5780
Classification Product Code
DWL  
Date Received 05/23/2013
Decision Date 07/10/2013
Decision

substantially equivalent

(SESE)
Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital
statement

statement

Type Special
Reviewed by Third Party No
Combination Product

No