The following data is part of a premarket notification filed by Precision Dynamics Corp. with the FDA for Franzen Needle Guide.
| Device ID | K830235 |
| 510k Number | K830235 |
| Device Name: | FRANZEN NEEDLE GUIDE |
| Classification | Needle, Aspiration And Injection, Reusable |
| Applicant | PRECISION DYNAMICS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-25 |
| Decision Date | 1983-02-23 |