VANISHPOINT BLOOD COLLECTION SET


Device Classification Name

set, administration, intravascular

510(k) Number K112512
Device Name VANISHPOINT BLOOD COLLECTION SET
Applicant
RETRACTABLE TECHNOLOGIES, INC.
511 lobo ln.
little elm, 
TX 
75068 -0009

Applicant Contact rhonda wells
Correspondent
RETRACTABLE TECHNOLOGIES, INC.
511 lobo ln.
little elm, 
TX 
75068 -0009

Correspodent Contact rhonda wells
Regulation Number 880.5440
Classification Product Code
FPA  
Subsequent Product Code
JKA  
Date Received 08/30/2011
Decision Date 10/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No