STD MED PRIMO PORT POLY


Device Classification Name

port & catheter, implanted, subcutaneous, intravascular

510(k) Number K080645
Device Name STD MED PRIMO PORT POLY
Applicant
STD MED, INC.
5 whitcomb avenue
ayer, 
MA 
01432

Applicant Contact pamela papineau
Correspondent
STD MED, INC.
5 whitcomb avenue
ayer, 
MA 
01432

Correspodent Contact pamela papineau
Regulation Number 880.5965
Classification Product Code
LJT  
Date Received 03/06/2008
Decision Date 05/02/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No