SIALO BALLOON DILATATION CATHETER


Device Classification Name

laparoscope, general & plastic surgery

510(k) Number K072749
Device Name SIALO BALLOON DILATATION CATHETER
Applicant
SIALO TECHNOLOGY, LTD.
20 hata’as st.
kfar saba, 

IL

44425

Applicant Contact ahava stein
Correspondent
SIALO TECHNOLOGY, LTD.
20 hata’as st.
kfar saba, 

IL

44425

Correspodent Contact ahava stein
Regulation Number 876.1500
Classification Product Code
GCJ  
Date Received 09/27/2007
Decision Date 05/14/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No