K010166
Substantially EquivalentIMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM
- Applicant
- Imagyn Medical Technologies, Inc.
- Product code
- IWJ
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Richland, MI, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.