The following data is part of a premarket notification filed by Surgical Products Corp. with the FDA for Ghi Wet Pencil.
| Device ID | K861614 |
| 510k Number | K861614 |
| Device Name: | GHI WET PENCIL |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SURGICAL PRODUCTS CORP. W140 N5446 LILLY RD. Menominee Fall, WI 53051 |
| Contact | Thomas Riley |
| Correspondent | Thomas Riley SURGICAL PRODUCTS CORP. W140 N5446 LILLY RD. Menominee Fall, WI 53051 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-29 |
| Decision Date | 1986-07-08 |