Solo+ Tympanostomy Tube Device (TTD)
Aventamed Dac · Ear, Nose, Throat
Open FDA's page for this record- Third party flag
- N
- City
- Bishopstown
- Advisory committee description
- Ear, Nose, Throat
- Address 1
- Rubicon Centre
- Address 2
- Rossa Ave.
- Statement or summary
- Summary
- Product code
- ETD
- Zip code
- T12 Y275
- Applicant
- Aventamed Dac
- Decision date
- 2024-05-20
- Decision code
- SESE
- Country code
- IE
- Device name
- Solo+ Tympanostomy Tube Device (TTD)
- Advisory committee
- EN
- Contact
- Keith Jansen
- K number
- K232702
- Date received
- 2023-09-05
- Review advisory committee
- EN
- Postal code
- T12 Y275
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Tube, Tympanostomy
- Medical specialty description
- Ear, Nose, Throat
- Regulation number
- 874.3880
- Device class
- 2
- Registration number
- 3016678045, 3011050570, 8010617, 3018094310, 3010610937, 3010132111, 3010155661, 1048735, 3002806953, 3005255160, 1057421, 1037007, 1052728, 2183744, 3012130335, 3006098219, 3002807315, 3012112259, 3009217531, 3017636737, 3010487482, 1045254, 1926681, 3043226252, 3013233645, 3012494290, 3003678543, 3013557562, 3012266672, 1317188, 1928237, 1519132, 3008719017, 3024021261, 9612501
- FEI number
- 3016678045, 3011050570, 3018094310, 3010610937, 3010132111, 3010155661, 1048735, 3002806953, 1000113735, 3005255160, 1037007, 2183744, 3003495548, 3012130335, 3006098219, 1000022662, 3002807315, 3012112259, 3009217531, 3017636737, 3010487482, 1045254, 1926681, 3043226252, 3013233645, 3012494290, 3003678543, 3013557562, 1317188, 6062, 1928237, 1519132, 3008719017, 3024021261, 3012266672