SEPRAGEL SINUS — Genzyme Corp. (510(k) K012532)
SEPRAGEL SINUS — Genzyme Corp. (510(k) K012532) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: SEPRAGEL SINUS; Applicant: Genzyme Corp.; Clearance track: 510(k).
| Device name | SEPRAGEL SINUS |
|---|---|
| Applicant | Genzyme Corp. |
| Clearance track | 510(k) |
| Submission number | K012532 |
| Decision | Substantially Equivalent |
| Decision date | 2001-10-30 |
| Date received | 2001-08-06 |
| Product code | LYA |
| Device class | 1 |
| Medical specialty | Ear, Nose, Throat |
| Applicant location | NJ, US |
| Source | openFDA device |
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$1999/mo
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