The following data is part of a premarket notification filed by Fiab Spa with the FDA for F7244, F7255, F7266, F7277, F7288, F7233, F7234 Series Of Battery-powered Cautery.
| Device ID | K083428 |
| 510k Number | K083428 |
| Device Name: | F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY |
| Classification | Unit, Cautery, Thermal, Battery-powered |
| Applicant | FIAB SPA VIA COSTOLI, 4 VICCHIO Firenze, IT 50039 |
| Contact | Silvia Calabro |
| Correspondent | Silvia Calabro FIAB SPA VIA COSTOLI, 4 VICCHIO Firenze, IT 50039 |
| Product Code | HQP |
| CFR Regulation Number | 886.4115 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-19 |
| Decision Date | 2009-09-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033695727152 | K083428 | 000 |