OTOLOGICAL VENTILATION TUBES-VARIOUS
FDA 510(k) clearance K830228 · decided 1983-03-07
Clearance details
- K-number
- K830228
- Device name
- OTOLOGICAL VENTILATION TUBES-VARIOUS
- Applicant
- Micromedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-01-24
- Decision date
- 1983-03-07
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- ETD
- Device class
- 2
- Regulation number
- 874.3880
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized recall (Z-1731-2014) | Summit Medical, Inc. | 2014-06-09 |