Hummingbird Tympanostomy Tube
FDA 510(k) clearance K151830 · decided 2015-09-21
Clearance details
- K-number
- K151830
- Device name
- Hummingbird Tympanostomy Tube
- Applicant
- Preceptis Medical
- Decision
- Substantially Equivalent
- Date received
- 2015-07-06
- Decision date
- 2015-09-21
- Days to decision
- 77 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
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.