The following data is part of a premarket notification filed by Gyrus Ent L.l.c. with the FDA for Diego Powered Dissector And Drill System.
| Device ID | K020594 |
| 510k Number | K020594 |
| Device Name: | DIEGO POWERED DISSECTOR AND DRILL SYSTEM |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett, TN 38133 |
| Contact | Gregory Sredin |
| Correspondent | Gregory Sredin 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 | 2002-02-22 |
| Decision Date | 2002-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925042360 | K020594 | 000 |
| 00821925011441 | K020594 | 000 |
| 00821925011458 | K020594 | 000 |
| 00821925026070 | K020594 | 000 |
| 00821925026155 | K020594 | 000 |
| 00821925026162 | K020594 | 000 |
| 00821925026582 | K020594 | 000 |
| 00821925028746 | K020594 | 000 |
| 00821925026223 | K020594 | 000 |
| 00821925026254 | K020594 | 000 |
| 00821925026247 | K020594 | 000 |
| 00821925026131 | K020594 | 000 |
| 00821925027268 | K020594 | 000 |
| 00821925011410 | K020594 | 000 |