The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Disposable Chiba-type Needle.
| Device ID | K813368 |
| 510k Number | K813368 |
| Device Name: | DISPOSABLE CHIBA-TYPE NEEDLE |
| Classification | Needle, Aspiration And Injection, Disposable |
| Applicant | DLP, INC. Walker, MI 49504 |
| Contact | James Devries |
| Correspondent | James Devries DLP, INC. Walker, MI 49504 |
| Product Code | GAA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-30 |
| Decision Date | 1982-01-05 |