The following data is part of a premarket notification filed by Clinical Technology Corp. with the FDA for Electrosurgical Cutting & Coagulation Device/acces.
| Device ID | K854231 |
| 510k Number | K854231 |
| Device Name: | ELECTROSURGICAL CUTTING & COAGULATION DEVICE/ACCES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | CLINICAL TECHNOLOGY CORP. 3750 MONROE AVE. P.O. BOX 23245 Rochester, NY 14692 |
| Contact | John Scoville |
| Correspondent | John Scoville CLINICAL TECHNOLOGY CORP. 3750 MONROE AVE. P.O. BOX 23245 Rochester, NY 14692 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-21 |
| Decision Date | 1986-05-02 |