MEDLINE RENEWAL REPROCESSED GYRUS-DIEGO SINUS APPLICATION BLADES
FDA 510(k) clearance K142022 · decided 2014-12-19
Clearance details
- K-number
- K142022
- Device name
- MEDLINE RENEWAL REPROCESSED GYRUS-DIEGO SINUS APPLICATION BLADES
- Applicant
- Medline Renewal
- Decision
- Substantially Equivalent
- Date received
- 2014-07-25
- Decision date
- 2014-12-19
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- NLY
- Device class
- 1
- Regulation number
- 874.4140
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Redmond, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.