The following data is part of a premarket notification filed by W&h Sterilization S.r.l. with the FDA for Lexa Plus Ris-311.
| Device ID | K213758 |
| 510k Number | K213758 |
| Device Name: | Lexa PLUS RIS-311 |
| Classification | Sterilizer, Steam |
| Applicant | W&H Sterilization S.r.l. Via Bolgara, 2 Brusaporta, IT 24060 |
| Contact | Paola Zampino |
| Correspondent | Angela Blackwell Blackwell Device Consulting P.O. BOX 718 Gresham, OR 97030 -0172 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-30 |
| Decision Date | 2022-08-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E30819933101 | K213758 | 000 |
| E30819933100 | K213758 | 000 |