The following data is part of a premarket notification filed by Getinge International, Inc. with the FDA for Steam Sterilization Equipment.
| Device ID | K821591 |
| 510k Number | K821591 |
| Device Name: | STEAM STERILIZATION EQUIPMENT |
| Classification | Sterilizer, Steam |
| Applicant | GETINGE INTERNATIONAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-01 |
| Decision Date | 1982-06-22 |