The following data is part of a premarket notification filed by Sialo Technology, Ltd. with the FDA for Sialo Drain.
| Device ID | K072334 |
| 510k Number | K072334 |
| Device Name: | SIALO DRAIN |
| Classification | Catheter, Drainage, Intraoral/extraoral |
| Applicant | SIALO TECHNOLOGY, LTD. 20 HATA'AS ST. Kfar Saba, IL 44425 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein SIALO TECHNOLOGY, LTD. 20 HATA'AS ST. Kfar Saba, IL 44425 |
| Product Code | OAJ |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-20 |
| Decision Date | 2008-07-18 |
| Summary: | summary |