BETATRANS I AND II


Device Classification Name

apparatus, autotransfusion

510(k) Number K951592
Device Name BETATRANS I AND II
Applicant
DUXBURY SCIENTIFIC INC.
183 whiting st.
hingham, 
MA 
02043

Applicant Contact robert m engler
Correspondent
DUXBURY SCIENTIFIC INC.
183 whiting st.
hingham, 
MA 
02043

Correspodent Contact robert m engler
Regulation Number 868.5830
Classification Product Code
CAC  
Date Received 04/06/1995
Decision Date 03/04/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No