VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520


Device Classification Name

valvulotome

510(k) Number K022823
Device Name VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520
Original Applicant
GEISTER MEDIZINTECHNIK GMBH
152b bridge st.
hot springs, 
NC 
28743

Original Contact dagmar maser
Regulation Number 870.4885
Classification Product Code
MGZ  
Date Received 08/26/2002
Decision Date 07/01/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No