Device |
tube, tympanostomy with semi-permeable membrane |
Regulation Description |
Tympanostomy tube with semipermeable membrane. |
Regulation Medical Specialty |
Ear Nose & Throat |
Review Panel |
Ear Nose & Throat |
Product Code | KQL |
Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Division of Dental and ENT Devices
(DHT1B)
|
Submission Type |
510(k)
|
Regulation Number |
874.3930
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|