The following data is part of a premarket notification filed by Medline Renewal with the FDA for Medline Renewal Reprocessed Gyrus-diego Sinus Application Blades.
| Device ID | K142022 |
| 510k Number | K142022 |
| Device Name: | MEDLINE RENEWAL REPROCESSED GYRUS-DIEGO SINUS APPLICATION BLADES |
| Classification | Microdebrider, Ent, High Speed, Single Use, Reprocessed |
| Applicant | MEDLINE RENEWAL 2747 SW 6th St Redmond, OR 97756 |
| Contact | Richard D Wynkoop |
| Correspondent | Richard D Wynkoop MEDLINE RENEWAL 2747 SW 6th St Redmond, OR 97756 |
| Product Code | NLY |
| CFR Regulation Number | 874.4140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-25 |
| Decision Date | 2014-12-19 |
| Summary: | summary |