HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
Device Facts
| Record ID | P850010 |
|---|---|
| Device Name | HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE |
| Applicant | Integra LifeSciences Corporation |
| Product Code | LMF · General, Plastic Surgery |
| Decision Date | Nov 8, 1985 |
| Decision | APPR |
| Regulation | 21 CFR 878.4490 |
| Device Class | Class 3 |
Regulatory Classification
Identification
An absorbable hemostatic agent or dressing is a device intended to produce hemostasis by accelerating the clotting process of blood. It is absorbable.