The following data is part of a premarket notification filed by Primus Sterilizer Company, Llc. with the FDA for Primus Steam Sterilizer Pss8-aa (16x16x26 Multi Functional Sterilizer), Lab/lo Sterilizer,primus Steam Sterilizer Pss8.
| Device ID | K093333 |
| 510k Number | K093333 |
| Device Name: | PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO STERILIZER,PRIMUS STEAM STERILIZER PSS8 |
| Classification | Sterilizer, Steam |
| Applicant | PRIMUS STERILIZER COMPANY, LLC. 117 SOUTH 25TH ST. Omaha, NE 68131 |
| Contact | Connie Mansfield |
| Correspondent | Connie Mansfield PRIMUS STERILIZER COMPANY, LLC. 117 SOUTH 25TH ST. Omaha, NE 68131 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-26 |
| Decision Date | 2010-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850005738237 | K093333 | 000 |
| 00850005738138 | K093333 | 000 |
| 00850005738145 | K093333 | 000 |
| 00850005738152 | K093333 | 000 |
| 00850005738169 | K093333 | 000 |
| 00850005738176 | K093333 | 000 |
| 00850005738183 | K093333 | 000 |
| 00850005738190 | K093333 | 000 |
| 00850005738206 | K093333 | 000 |
| 00850005738213 | K093333 | 000 |
| 00850005738220 | K093333 | 000 |
| 00850005738121 | K093333 | 000 |