The following data is part of a premarket notification filed by Getinge International, Inc. with the FDA for Gas Sterilization Equipment.
| Device ID | K821842 |
| 510k Number | K821842 |
| Device Name: | GAS STERILIZATION EQUIPMENT |
| Classification | Sterilizer, Ethylene-oxide Gas |
| Applicant | GETINGE INTERNATIONAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FLF |
| CFR Regulation Number | 880.6860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-22 |
| Decision Date | 1982-07-28 |