The following data is part of a premarket notification filed by Belimed Sauter Ag with the FDA for Belimed Steam Sterilizer Top 5000, Series 8, Models: 6-0-12 Vs1 And Vs2.
| Device ID | K090339 |
| 510k Number | K090339 |
| Device Name: | BELIMED STEAM STERILIZER TOP 5000, SERIES 8, MODELS: 6-0-12 VS1 AND VS2 |
| Classification | Sterilizer, Steam |
| Applicant | BELIMED SAUTER AG 2284 CLEMENTS FERRY RD. Charleston, SC 29412 |
| Contact | Chris P Mannarino |
| Correspondent | Chris P Mannarino BELIMED SAUTER AG 2284 CLEMENTS FERRY RD. Charleston, SC 29412 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-10 |
| Decision Date | 2009-09-23 |
| Summary: | summary |