GYNEFLEX— 510(k) K021115
Substantially EquivalentNaissance Holdings, LC
FDA 510(k) clearance K021115 for GYNEFLEX, Substantially Equivalent on 2002-12-20. Applicant: Naissance Holdings, LC.
Clearance details
- Applicant
- Naissance Holdings, LC
- Product code
- Code HIR
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wahington, DC, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.