The following data is part of a premarket notification filed by Primus Sterilizer Co., Inc. with the FDA for Primus Pss Series Sterilizers.
| Device ID | K926185 |
| 510k Number | K926185 |
| Device Name: | PRIMUS PSS SERIES STERILIZERS |
| Classification | Sterilizer, Steam |
| Applicant | PRIMUS STERILIZER CO., INC. 4256 REDMAN AVE. Omaha, NE 68111 |
| Contact | Roberty M Lachoweiz |
| Correspondent | Roberty M Lachoweiz PRIMUS STERILIZER CO., INC. 4256 REDMAN AVE. Omaha, NE 68111 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-08 |
| Decision Date | 1994-05-09 |