The following data is part of a premarket notification filed by Spintech, Inc. with the FDA for The Wand Plus Computer Controlled Anesthetic Delivery System.
| Device ID | K010692 |
| 510k Number | K010692 |
| Device Name: | THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM |
| Classification | Syringe, Piston |
| Applicant | SPINTECH, INC. 2000 M ST. NW SUITE 700 Washington, DC 20036 |
| Contact | Daniel J Manelli |
| Correspondent | Daniel J Manelli SPINTECH, INC. 2000 M ST. NW SUITE 700 Washington, DC 20036 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-08 |
| Decision Date | 2001-06-29 |