The following data is part of a premarket notification filed by Kaltenbach & Voigt Gmbh with the FDA for Mastersurg / Expertsurg.
| Device ID | K140308 |
| 510k Number | K140308 |
| Device Name: | MASTERSURG / EXPERTSURG |
| Classification | Controller, Foot, Handpiece And Cord |
| Applicant | KALTENBACH & VOIGT GMBH BISMARCKRING 39 Biberach, DE 88400 |
| Contact | Stefan Trampler |
| Correspondent | Stefan Trampler KALTENBACH & VOIGT GMBH BISMARCKRING 39 Biberach, DE 88400 |
| Product Code | EBW |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-07 |
| Decision Date | 2014-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKAV101386620 | K140308 | 000 |
| EKAV100880000 | K140308 | 000 |
| EKAV100904700 | K140308 | 000 |
| EKAV100910050 | K140308 | 000 |
| EKAV100910100 | K140308 | 000 |
| EKAV100911000 | K140308 | 000 |
| EKAV100912000 | K140308 | 000 |
| EKAV101023320 | K140308 | 000 |
| EKAV101023330 | K140308 | 000 |
| EKAV101149000 | K140308 | 000 |
| EKAV100987570 | K140308 | 000 |
| EKAV101375400 | K140308 | 000 |
| EKAV101375410 | K140308 | 000 |
| EKAV101386480 | K140308 | 000 |
| EKAV100835000 | K140308 | 000 |