GENT-L-KARE LACERATION TRAYS— 510(k) K950850
Substantially Equivalent for Some IndicationsPremium Plastics, Inc.
FDA 510(k) clearance K950850 for GENT-L-KARE LACERATION TRAYS, Substantially Equivalent for Some Indications on 1995-03-14. Applicant: Premium Plastics, Inc..
Clearance details
- Applicant
- Premium Plastics, Inc.
- Product code
- Code FRG
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Chicago, IL, US
Adverse events under product code FRG
product code FRG- Other
- 3
- Total
- 3
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.