PATIENT SAFE SYRINGE


Device Classification Name

syringe, piston

510(k) Number K072654
Device Name PATIENT SAFE SYRINGE
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 880.5860
Classification Product Code
FMF  
Date Received 09/20/2007
Decision Date 12/14/2007
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