510(k) K050340
K050340 is an FDA 510(k) premarket notification submitted by Micromedics, Inc. for the device "MICROMEDICS SPHENOID SINUS STENT". The FDA issued a decision of Substantially Equivalent on April 27, 2005. The device falls under product code KAM (Cannula, Sinus), a Class I device regulated under 21 CFR 878.4800. Micromedics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 27, 2005
- Date Received
- February 11, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cannula, Sinus
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type