510(k) K960836
K960836 is an FDA 510(k) premarket notification submitted by O.R. Solutions, Inc. for the device "DMS-9000". The FDA issued a decision of Substantially Equivalent on September 12, 1996. The device falls under product code LRJ (Disinfectant, Medical Devices), a Class I device regulated under 21 CFR 880.6890. O.R. Solutions, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 1996
- Date Received
- February 29, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Disinfectant, Medical Devices
- Device Class
- Class I
- Regulation Number
- 880.6890
- Review Panel
- HO
- Submission Type