ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)— 510(k) K970873
Substantially EquivalentAmerican Medical Devices, Inc.
FDA 510(k) clearance K970873 for ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.), Substantially Equivalent on 1997-05-20. Applicant: American Medical Devices, Inc..
Clearance details
- Applicant
- American Medical Devices, Inc.
- Product code
- Code HMX
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Atlanta, GA, US
Adverse events under product code HMX
product code HMX- Other
- 1
- Total
- 1
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.