DURALASTIC I— 510(k) K955368
Substantially EquivalentAllied Biomedical Corp.
FDA 510(k) clearance K955368 for DURALASTIC I, Substantially Equivalent on 1996-02-08. Applicant: Allied Biomedical Corp.. Device class: 2.
Clearance details
- Applicant
- Allied Biomedical Corp.
- Product code
- Code MIB
- Device class
- Class 2
- Regulation
- 21 CFR 874.3620
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Goose Creek, SC, US
Recent devices under product code MIB
view allMore clearances from Allied Biomedical Corp.
view allAdverse events under product code MIB
product code MIB- Injury
- 146
- Total
- 146
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.