The following data is part of a premarket notification filed by W&h Sterilization S.r.l. with the FDA for Mn-111.
| Device ID | K172825 |
| 510k Number | K172825 |
| Device Name: | MN-111 |
| Classification | Sterilizer, Steam |
| Applicant | W&H Sterilization S.r.l. Via Bolgara, 2 Brusaporto, IT |
| Contact | Marco Parolini |
| Correspondent | Marco Parolini W&H Sterilization S.r.l. Via Bolgara, 2 Brusaporto, IT |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-18 |
| Decision Date | 2018-05-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E308199434200 | K172825 | 000 |
| 00304040185100 | K172825 | 000 |
| E308199431310 | K172825 | 000 |
| E308199434310 | K172825 | 000 |
| E308199431000 | K172825 | 000 |
| E308199431010 | K172825 | 000 |
| E308199431100 | K172825 | 000 |
| E308199431110 | K172825 | 000 |
| E308199431200 | K172825 | 000 |
| E308199434000 | K172825 | 000 |
| E308199434010 | K172825 | 000 |
| E308199434100 | K172825 | 000 |
| E308199434110 | K172825 | 000 |
| 00304040185094 | K172825 | 000 |