510(k) K072891
K072891 is an FDA 510(k) premarket notification submitted by Acclarent, Inc. for the device "SINUS SPACER". The FDA issued a decision of Substantially Equivalent on March 19, 2008. The device falls under product code KAM (Cannula, Sinus), a Class I device regulated under 21 CFR 878.4800. Acclarent, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 19, 2008
- Date Received
- October 10, 2007
- 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