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
|
|
Correspondent Contact |
AHAVA STEIN |
Regulation Number | 878.4200
|
Classification Product Code |
|
Date Received | 08/20/2007 |
Decision Date | 07/18/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|