510(k) K111250
K111250 is an FDA 510(k) premarket notification submitted by Dr. Fresh, Inc. for the device "DRY MOUTH MOUTHWASH". The FDA issued a decision of Substantially Equivalent on April 27, 2012. The device falls under product code LFD (Saliva, Artificial), a Class U device. Dr. Fresh, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 27, 2012
- Date Received
- May 4, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Saliva, Artificial
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type