The following data is part of a premarket notification filed by Mdt Corp., Inc. with the FDA for Bovie Model X-10, X-10i, Electrosurgical Generator.
| Device ID | K910663 |
| 510k Number | K910663 |
| Device Name: | BOVIE MODEL X-10, X-10I, ELECTROSURGICAL GENERATOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MDT CORP., INC. 1777 EAST HENRIETTA RD.(14623) P.O. BOX 23077 Rochester, NY 14692 |
| Contact | Mark Smith |
| Correspondent | Mark Smith MDT CORP., INC. 1777 EAST HENRIETTA RD.(14623) P.O. BOX 23077 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 | 1991-02-14 |
| Decision Date | 1991-05-09 |