The following data is part of a premarket notification filed by Cefla S.c. with the FDA for Family Of Steam Sterilizers B 28 Series.
| Device ID | K151597 |
| 510k Number | K151597 |
| Device Name: | Family Of Steam Sterilizers B 28 Series |
| Classification | Sterilizer, Steam |
| Applicant | CEFLA S.C. VIA SELICE PROVINCIALE 23/A Imola, IT 40026 |
| Contact | Silvia Sansavini |
| Correspondent | Maurizio Pantaleoni ISEMED SRL VIA A.BONETTI 3/A Imola, IT 40026 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-12 |
| Decision Date | 2016-03-04 |