510(k) K082762
K082762 is an FDA 510(k) premarket notification submitted by Aardvark Medical for the device "AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE". The FDA issued a decision of Substantially Equivalent on November 12, 2008. The device falls under product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered), a Class II device regulated under 21 CFR 878.4780. Aardvark Medical has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 12, 2008
- Date Received
- September 22, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Apparatus, Suction, Ward Use, Portable, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 878.4780
- Review Panel
- SU
- Submission Type