The following data is part of a premarket notification filed by Primus Sterilizer Company, Llc. with the FDA for Primus Steam Sterilizer, Models Pss5-g-1 And Pss5-m.
| Device ID | K082817 |
| 510k Number | K082817 |
| Device Name: | PRIMUS STEAM STERILIZER, MODELS PSS5-G-1 AND PSS5-M |
| Classification | Sterilizer, Steam |
| Applicant | PRIMUS STERILIZER COMPANY, LLC. 5520 10TH ST. Great Bend, KS 67530 |
| Contact | Lyle Lohrmeyer |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-09-25 |
| Decision Date | 2009-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850005738114 | K082817 | 000 |
| 00850005738084 | K082817 | 000 |