BLACKSTAR(TM) STAR SYSTEM — Xomed-Treace, Inc. (510(k) K945659)
BLACKSTAR(TM) STAR SYSTEM — Xomed-Treace, Inc. (510(k) K945659) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: BLACKSTAR(TM) STAR SYSTEM; Applicant: Xomed-Treace, Inc.; Clearance track: 510(k).
| Device name | BLACKSTAR(TM) STAR SYSTEM |
|---|---|
| Applicant | Xomed-Treace, Inc. |
| Clearance track | 510(k) |
| Submission number | K945659 |
| Decision | Substantially Equivalent |
| Decision date | 1995-01-09 |
| Date received | 1994-11-17 |
| Product code | ERL |
| Device class | 2 |
| Medical specialty | Ear, Nose, Throat |
| Applicant location | FL, US |
| Source | openFDA device |
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$1999/mo
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