PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380


information about

Device Classification Name

set, administration, intravascular

510(k) Number K002138
Device Name PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380
Original Applicant
MAERSK MEDICAL A/S
12744 san fernando rd.
sylmar, 
CA 
91342

Original Contact jennifer lyons
Regulation Number 880.5440
Classification Product Code
FPA  
Subsequent Product Code
FPK  
Date Received 07/17/2000
Decision Date 08/29/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls