UNASSIGNED


Device Classification Name

set, administration, intravascular

510(k) Number K080544
Device Name UNASSIGNED
Applicant
MEDCOMP
1499 delp dr.
harleysville, 
PA 
19438

Applicant Contact jean callow
Correspondent
MEDCOMP
1499 delp dr.
harleysville, 
PA 
19438

Correspodent Contact jean callow
Regulation Number 880.5440
Classification Product Code
FPA  
Date Received 02/27/2008
Decision Date 08/14/2008
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