510(k) K142282
K142282 is an FDA 510(k) premarket notification submitted by Preceptis Medical for the device "HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS)". The FDA issued a decision of Substantially Equivalent on April 23, 2015. The device falls under product code ETD (Tube, Tympanostomy), a Class II device regulated under 21 CFR 874.3880. Preceptis Medical has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 23, 2015
- Date Received
- August 15, 2014
- 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