The following data is part of a premarket notification filed by Dentalez Group with the FDA for Quick-connect 360 Swivel Tip Autoclavable Syringe.
| Device ID | K931093 |
| 510k Number | K931093 |
| Device Name: | QUICK-CONNECT 360 SWIVEL TIP AUTOCLAVABLE SYRINGE |
| Classification | Unit, Operative Dental |
| Applicant | DENTALEZ GROUP 1816 COLONIAL VILLAGE LN. Lancaster, PA 17601 |
| Contact | Bill Ransing |
| Correspondent | Bill Ransing DENTALEZ GROUP 1816 COLONIAL VILLAGE LN. Lancaster, PA 17601 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-03 |
| Decision Date | 1994-01-21 |