The following data is part of a premarket notification filed by M.o.c.o.m. Srl with the FDA for Millennium Series, Including Millennium B, B+, B2 And Bu.
| Device ID | K050263 |
| 510k Number | K050263 |
| Device Name: | MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU |
| Classification | Sterilizer, Steam |
| Applicant | M.O.C.O.M. SRL VIA DELLE AZALEE 1 Buccinasco (mi), IT 20090 |
| Contact | Daniele Tosi |
| Correspondent | Daniele Tosi M.O.C.O.M. SRL VIA DELLE AZALEE 1 Buccinasco (mi), IT 20090 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-04 |
| Decision Date | 2006-11-21 |
| Summary: | summary |