The following data is part of a premarket notification filed by Gyrus Ent L.l.c. with the FDA for Diego Rf Powered Dissector And Drill System Console.
| Device ID | K034004 |
| 510k Number | K034004 |
| Device Name: | DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett, TN 38133 |
| Contact | Alicia Farage |
| Correspondent | Alicia Farage GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett, TN 38133 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-24 |
| Decision Date | 2004-03-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925025394 | K034004 | 000 |
| 00821925026599 | K034004 | 000 |
| 00821925026926 | K034004 | 000 |
| 00821925025929 | K034004 | 000 |
| 00821925025936 | K034004 | 000 |
| 00821925025974 | K034004 | 000 |
| 00821925025967 | K034004 | 000 |
| 00821925025943 | K034004 | 000 |
| 00821925025950 | K034004 | 000 |
| 00821925011427 | K034004 | 000 |