510(k) K142022
- Device
- MEDLINE RENEWAL REPROCESSED GYRUS-DIEGO SINUS APPLICATION BLADES
- Applicant
- MEDLINE RENEWAL
- 510(k) number
- K142022
- Product code
- NLY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-12-19
- Date received
- 2014-07-25
- Regulation
- 874.4140
- Classification name
- Microdebrider, Ent, High Speed, Single Use, Reprocessed
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD D WYNKOOP
- Address
- 2747 SW 6th St. Redmond OR US 97756 97756
FDA Registration Numbers#
- 3003800209
- 3032391
- 3010163695
Source Documents#
Legacy Summary#
summary
FDA Review#
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