PHANTOM XL INSULATED DILATORS
FDA 510(k) clearance K140088 · decided 2014-09-25
Clearance details
- K-number
- K140088
- Device name
- PHANTOM XL INSULATED DILATORS
- Applicant
- Tedan Surgical Innovations, LLC
- Decision
- Substantially Equivalent
- Date received
- 2014-01-14
- Decision date
- 2014-09-25
- Days to decision
- 254 days
- Clearance type
- Traditional
- Product code
- PDQ
- Device class
- 2
- Regulation number
- 874.1820
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Sugar Land, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.