The following data is part of a premarket notification filed by Gyrus Ent L.l.c. with the FDA for Turbo 7000 Shaver And Drill Console; Turbo 7000 Handpieces; Essential Shaver/burrs;.
| Device ID | K992994 |
| 510k Number | K992994 |
| Device Name: | TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS; |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett, TN 38133 |
| Contact | Jeff Cobb |
| Correspondent | Jeff Cobb 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 | 1999-09-07 |
| Decision Date | 1999-11-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925030855 | K992994 | 000 |
| 00821925011397 | K992994 | 000 |
| 00821925011403 | K992994 | 000 |
| 00821925011434 | K992994 | 000 |
| 00821925011465 | K992994 | 000 |
| 00821925011472 | K992994 | 000 |
| 00821925011489 | K992994 | 000 |
| 00821925011496 | K992994 | 000 |
| 00821925011502 | K992994 | 000 |
| 00821925028715 | K992994 | 000 |
| 00821925028722 | K992994 | 000 |
| 00821925029651 | K992994 | 000 |
| 00821925030848 | K992994 | 000 |
| 00821925011380 | K992994 | 000 |