The following data is part of a premarket notification filed by Valley Forge Scientific Corp. with the FDA for Bi-tech I Bipolar Coagulator/cutting System.
| Device ID | K924188 |
| 510k Number | K924188 |
| Device Name: | BI-TECH I BIPOLAR COAGULATOR/CUTTING SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | VALLEY FORGE SCIENTIFIC CORP. P.O. BOX 925 Valley Forge, PA 19482 |
| Contact | Thomas J Gilloway |
| Correspondent | Thomas J Gilloway VALLEY FORGE SCIENTIFIC CORP. P.O. BOX 925 Valley Forge, PA 19482 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-20 |
| Decision Date | 1992-12-10 |