510(k) K061058
K061058 is an FDA 510(k) premarket notification submitted by Adept Medical, Ltd. for the device "NEOZOLINE VENTILATION TUBES". The FDA issued a decision of Substantially Equivalent on July 12, 2006. The device falls under product code ETD (Tube, Tympanostomy), a Class II device regulated under 21 CFR 874.3880.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 12, 2006
- Date Received
- April 17, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Tympanostomy
- Device Class
- Class II
- Regulation Number
- 874.3880
- Review Panel
- EN
- Submission Type