SIALO DRAIN


Device Classification Name

catheter, drainage, intraoral/extraoral

510(k) Number K072334
Device Name SIALO DRAIN
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 878.4200
Classification Product Code
OAJ  
Date Received 08/20/2007
Decision Date 07/18/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No