DERMASSIST(TM) HYDROGEL SATURATED GAUZE DRESSING— 510(k) K946030
Substantially EquivalentWilshire Medical Products
FDA 510(k) clearance K946030 for DERMASSIST(TM) HYDROGEL SATURATED GAUZE DRESSING, Substantially Equivalent on 1995-02-27. Applicant: Wilshire Medical Products.
Clearance details
- Applicant
- Wilshire Medical Products
- Product code
- Code MGQ
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dallas, TX, US
Adverse events under product code MGQ
product code MGQ- Death
- 16
- Total
- 16
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.