The following data is part of a premarket notification filed by Fiab Spa with the FDA for Fiab Spa, Models F7244, F7233, F7234, F7277.
| Device ID | K100333 |
| 510k Number | K100333 |
| Device Name: | FIAB SPA, MODELS F7244, F7233, F7234, F7277 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | FIAB SPA VIA COSTOLI, 4 Vicchio, Fi, IT 50039 |
| Contact | Francesco Batistini |
| Correspondent | Francesco Batistini FIAB SPA VIA COSTOLI, 4 Vicchio, Fi, IT 50039 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-05 |
| Decision Date | 2010-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18033695727456 | K100333 | 000 |
| 28033695727446 | K100333 | 000 |
| 08033695727183 | K100333 | 000 |
| 08033695727169 | K100333 | 000 |
| 28033695727149 | K100333 | 000 |