The following data is part of a premarket notification filed by Clinical Technology Corp. with the FDA for Bovie X-10 Electrosurgical Generator(unit).
| Device ID | K844565 |
| 510k Number | K844565 |
| Device Name: | BOVIE X-10 ELECTROSURGICAL GENERATOR(UNIT) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | CLINICAL TECHNOLOGY CORP. 3750 MONROE AVE. P.O. BOX 23245 Rochester, NY 14692 |
| Contact | Elaine C Jeveli |
| Correspondent | Elaine C Jeveli 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 | 1984-11-23 |
| Decision Date | 1985-02-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925010130 | K844565 | 000 |
| 00821925009646 | K844565 | 000 |