The following data is part of a premarket notification filed by Sialo Technology, Ltd. with the FDA for Stone Grasping Basket, Model Pd-t1 2115.
| Device ID | K082735 |
| 510k Number | K082735 |
| Device Name: | STONE GRASPING BASKET, MODEL PD-T1 2115 |
| Classification | Laparoscope, General & Plastic Surgery |
| 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 | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-18 |
| Decision Date | 2009-03-13 |
| Summary: | summary |