MACLIN POWER INTRAVASCULAR ADMINISTRATION SET


Device Classification Name

set, administration, intravascular

510(k) Number K121511
Device Name MACLIN POWER INTRAVASCULAR ADMINISTRATION SET
Applicant
MACLIN POWER INC.
via marzia, 9
abano terme, pd, 

IT

35031

Applicant Contact enrico bisson
Correspondent
MACLIN POWER INC.
via marzia, 9
abano terme, pd, 

IT

35031

Correspodent Contact enrico bisson
Regulation Number 880.5440
Classification Product Code
FPA  
Date Received 05/21/2012
Decision Date 03/07/2013
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