The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Ima Electrocautery Electrode Cat. #60002/60003.
| Device ID | K912229 |
| 510k Number | K912229 |
| Device Name: | IMA ELECTROCAUTERY ELECTRODE CAT. #60002/60003 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
| Contact | Roger W Brink |
| Correspondent | Roger W Brink DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-20 |
| Decision Date | 1991-09-25 |