The following data is part of a premarket notification filed by Spintech, Inc. with the FDA for Safetywand Disposable Handpiece.
| Device ID | K023722 |
| 510k Number | K023722 |
| Device Name: | SAFETYWAND DISPOSABLE HANDPIECE |
| Classification | Syringe, Cartridge |
| 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 | EJI |
| CFR Regulation Number | 872.6770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-05 |
| Decision Date | 2003-09-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20618874000176 | K023722 | 000 |
| 10618874000070 | K023722 | 000 |
| 10618874000087 | K023722 | 000 |
| 10618874000094 | K023722 | 000 |
| 10618874000148 | K023722 | 000 |
| 10618874000155 | K023722 | 000 |
| 10618874000162 | K023722 | 000 |
| 10618874000179 | K023722 | 000 |
| 20618874000060 | K023722 | 000 |
| 20618874000077 | K023722 | 000 |
| 20618874000084 | K023722 | 000 |
| 20618874000091 | K023722 | 000 |
| 20618874000145 | K023722 | 000 |
| 20618874000152 | K023722 | 000 |
| 20618874000169 | K023722 | 000 |
| 10618874000063 | K023722 | 000 |