510(k) K071178
K071178 is an FDA 510(k) premarket notification submitted by Otomedics Advanced Medical Technologies, Ltd. for the device "OTOMEDICS SOFT TYMPANOSTOMY TUBE". The FDA issued a decision of Substantially Equivalent on June 22, 2007. 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
- June 22, 2007
- Date Received
- April 27, 2007
- 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