The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Diff 4 System.
| Device ID | K830441 |
| 510k Number | K830441 |
| Device Name: | DIFF 4 SYSTEM |
| Classification | Unit, Electrosurgical, And Accessories, Dental |
| Applicant | COULTER ELECTRONICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EKZ |
| CFR Regulation Number | 872.4920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-10 |
| Decision Date | 1983-05-16 |