510(k) K911120
K911120 is an FDA 510(k) premarket notification submitted by Hamo USA, Inc. for the device "DECONTAMINATING MACHINES, LS-850, LS-76, DW/T-216, T-21". The FDA issued a decision of Substantially Equivalent on February 3, 1994. The device falls under product code MEC (Disinfector, Medical Devices), a Class II device regulated under 21 CFR 880.6992.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 3, 1994
- Date Received
- March 11, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Disinfector, Medical Devices
- Device Class
- Class II
- Regulation Number
- 880.6992
- Review Panel
- HO
- Submission Type