GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER— 510(k) K893135
Substantially EquivalentPremium Plastics, Inc.
FDA 510(k) clearance K893135 for GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER, Substantially Equivalent on 1989-06-22. Applicant: Premium Plastics, Inc..
Clearance details
- Applicant
- Premium Plastics, Inc.
- Product code
- Code JOL
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elkhorn, WI, US
Adverse events under product code JOL
product code JOL- Death
- 7
- Injury
- 177
- Malfunction
- 1,306
- Other
- 1
- Total
- 1,491
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.