The following data is part of a premarket notification filed by Today's Machining & Design, Inc. with the FDA for Ace-kyle Dye Injection Needle P/n 14082.
| Device ID | K853604 |
| 510k Number | K853604 |
| Device Name: | ACE-KYLE DYE INJECTION NEEDLE P/N 14082 |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | TODAY'S MACHINING & DESIGN, INC. 2368 EASTMAN AVE #14 Ventura, CA 93002 |
| Contact | Mark Wilson |
| Correspondent | Mark Wilson TODAY'S MACHINING & DESIGN, INC. 2368 EASTMAN AVE #14 Ventura, CA 93002 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-28 |
| Decision Date | 1985-11-12 |