S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0


the company

Device Classification Name

console, heart-lung machine, cardiopulmonary bypass

510(k) Number K002116
Device Name S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0
Original Applicant
MEDICAL DEVICE CONSULTANTS, INC.
49 plain st.
north attleboro, 
MA 
02760 -4153

Original Contact cynthia j nolte
Regulation Number 870.4220
Classification Product Code
DTQ  
Date Received 07/13/2000
Decision Date 08/09/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Special
Reviewed by Third Party No

Combination Product

No