The following data is part of a premarket notification filed by Primus Sterilizer Co., Inc. with the FDA for Primus Steam Sterilizers.
| Device ID | K991575 |
| 510k Number | K991575 |
| Device Name: | PRIMUS STEAM STERILIZERS |
| Classification | Sterilizer, Steam |
| Applicant | PRIMUS STERILIZER CO., INC. 117 SOUTH 25TH ST. Omaha, NE 68131 |
| Contact | Jeff Reed |
| Correspondent | Jeff Reed PRIMUS STERILIZER CO., INC. 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 | 1999-05-06 |
| Decision Date | 1999-12-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850005738107 | K991575 | 000 |
| 00850005738091 | K991575 | 000 |
| 00850005738077 | K991575 | 000 |
| 00850005738060 | K991575 | 000 |
| 00850005738053 | K991575 | 000 |
| 00850005738046 | K991575 | 000 |
| 00850005738039 | K991575 | 000 |
| 00850005738022 | K991575 | 000 |
| 00850005738008 | K991575 | 000 |