TRITON MEIDCAL TMED IV-SET


Device Classification Name

set, administration, intravascular

510(k) Number K073444
Device Name TRITON MEIDCAL TMED IV-SET
Applicant
TRITON MEDICAL, LLC
1705 s. capital of texas hwy
austin, 
TX 
78746

Applicant Contact ian p gordon
Correspondent
TRITON MEDICAL, LLC
1705 s. capital of texas hwy
austin, 
TX 
78746

Correspodent Contact ian p gordon
Regulation Number 880.5440
Classification Product Code
FPA  
Date Received 12/07/2007
Decision Date 08/18/2008
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