The following data is part of a premarket notification filed by Getinge Disinfection, Inc. with the FDA for Decomat 4656.
| Device ID | K950566 |
| 510k Number | K950566 |
| Device Name: | DECOMAT 4656 |
| Classification | Device, Pasteurization, Hot Water |
| Applicant | GETINGE DISINFECTION, INC. 1415 HOOPER AVE. BOX H Toms River, NJ 08753 |
| Contact | Vincent J Koren |
| Correspondent | Vincent J Koren GETINGE DISINFECTION, INC. 1415 HOOPER AVE. BOX H Toms River, NJ 08753 |
| Product Code | LDS |
| CFR Regulation Number | 880.6991 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-08 |
| Decision Date | 1995-10-19 |