The following data is part of a premarket notification filed by Jurgan Development & Mfg., Ltd. with the FDA for Jurgan Pin Ball.
| Device ID | K831072 |
| 510k Number | K831072 |
| Device Name: | JURGAN PIN BALL |
| Classification | Fixation Accessory |
| Applicant | JURGAN DEVELOPMENT & MFG., LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LYT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-04 |
| Decision Date | 1983-06-08 |