The following data is part of a premarket notification filed by Spintech, Inc. with the FDA for Wand Plus.
| Device ID | K992819 |
| 510k Number | K992819 |
| Device Name: | WAND PLUS |
| Classification | Syringe, Cartridge |
| Applicant | SPINTECH, INC. 2000 M. ST. NW # 700 Washington, DC 20036 |
| Contact | Daniel J Manelli |
| Correspondent | Daniel J Manelli SPINTECH, INC. 2000 M. ST. NW # 700 Washington, DC 20036 |
| Product Code | EJI |
| CFR Regulation Number | 872.6770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-20 |
| Decision Date | 2000-05-11 |
| Summary: | summary |