The following data is part of a premarket notification filed by Getinge Usa, Inc with the FDA for Model 833hc Vacuum/gravity Steam Sterilizer.
| Device ID | K031259 |
| 510k Number | K031259 |
| Device Name: | MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER |
| Classification | Sterilizer, Steam |
| Applicant | GETINGE USA, INC 1777 EAST HENRIETTA RD. Rochester, NY 14623 -3133 |
| Contact | Frederick R Catt |
| Correspondent | Frederick R Catt GETINGE USA, INC 1777 EAST HENRIETTA RD. Rochester, NY 14623 -3133 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-21 |
| Decision Date | 2003-05-12 |
| Summary: | summary |