MODEL 4815 ADAPTER


codes

Device Classification Name

reservoir, blood, cardiopulmonary bypass

510(k) Number K002496
Device Name MODEL 4815 ADAPTER
Original Applicant
PACE MEDICAL
391 totten pond rd.
waltham, 
MA 
02451

Original Contact robert c mace
Regulation Number 870.4400
Classification Product Code
DTN  
Date Received 08/14/2000
Decision Date 10/10/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No