The following data is part of a premarket notification filed by Gyrus Ent L.l.c. with the FDA for Diego Powered Dissector Handpiece With Starlink Image-guided Adapter Mounting Interface.
| Device ID | K030343 |
| 510k Number | K030343 |
| Device Name: | DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE |
| Classification | Neurological Stereotaxic Instrument |
| 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 | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-03 |
| Decision Date | 2003-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925026186 | K030343 | 000 |
| 00821925026179 | K030343 | 000 |
| 00821925026148 | K030343 | 000 |