The following data is part of a premarket notification filed by Hamo Usa, Inc. with the FDA for Decontaminating Machines, Ls-850, Ls-76, Dw/t-216, T-21.
| Device ID | K911120 |
| 510k Number | K911120 |
| Device Name: | DECONTAMINATING MACHINES, LS-850, LS-76, DW/T-216, T-21 |
| Classification | Disinfector, Medical Devices |
| Applicant | HAMO USA, INC. 10100 N.W. 116TH WAY, SUITE 14 Miami, FL 33178 |
| Contact | Alfredo Munoz |
| Correspondent | Alfredo Munoz HAMO USA, INC. 10100 N.W. 116TH WAY, SUITE 14 Miami, FL 33178 |
| Product Code | MEC |
| CFR Regulation Number | 880.6992 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-11 |
| Decision Date | 1994-02-03 |