510(k) K140542
K140542 is an FDA 510(k) premarket notification submitted by Rhinosystems, Inc. for the device "NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER". The FDA issued a decision of Substantially Equivalent on June 27, 2014. The device falls under product code KMA (Irrigator, Powered Nasal), a Class I device regulated under 21 CFR 874.5550.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 27, 2014
- Date Received
- March 4, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Irrigator, Powered Nasal
- Device Class
- Class I
- Regulation Number
- 874.5550
- Review Panel
- EN
- Submission Type