UNIGLACTIN— 510(k) K072645
Substantially EquivalentUnited Medical Industries Co. , Ltd.
FDA 510(k) clearance K072645 for UNIGLACTIN, Substantially Equivalent on 2007-11-07. Applicant: United Medical Industries Co. , Ltd.. Device class: 2.
Clearance details
- Applicant
- United Medical Industries Co. , Ltd.
- Product code
- Code GAM
- Device class
- Class 2
- Regulation
- 21 CFR 878.4493
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Riyadh, Central Province, SA
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More clearances from United Medical Industries Co. , Ltd.
view allAdverse events under product code GAM
product code GAM- Death
- 45
- Injury
- 5,711
- Malfunction
- 30,744
- Other
- 4
- Total
- 36,504
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.