ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR


Device Classification Name

ring, annuloplasty

510(k) Number K072655
Device Name ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR
Applicant
Genesee BioMedical, Inc.
1308 south jason st.
denver, 
CO 
80223

Applicant Contact john t wright, ph.d.
Correspondent
Genesee BioMedical, Inc.
1308 south jason st.
denver, 
CO 
80223

Correspodent Contact john t wright, ph.d.
Regulation Number 870.3800
Classification Product Code
KRH  
Date Received 09/20/2007
Decision Date 10/23/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No