510(k) K092580
K092580 is an FDA 510(k) premarket notification submitted by Tidi Products,Llc for the device "TIDI FACEMASK". The FDA issued a decision of Substantially Equivalent on February 23, 2010. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Tidi Products,Llc has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 23, 2010
- Date Received
- August 21, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mask, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type