OXFORD HUMAN MILK PASTEURISER— 510(k) K801246
Substantially EquivalentVickers America Medical Corp.
FDA 510(k) clearance K801246 for OXFORD HUMAN MILK PASTEURISER, Substantially Equivalent on 1980-10-03. Applicant: Vickers America Medical Corp.. Device class: 2.
Clearance details
- Applicant
- Vickers America Medical Corp.
- Product code
- Code HGX
- Device class
- Class 2
- Regulation
- 21 CFR 884.5160
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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More clearances from Vickers America Medical Corp.
view allAdverse events under product code HGX
product code HGX- Injury
- 758
- Other
- 2
- Total
- 760
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.