RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D— 510(k) K071173
Substantially EquivalentOssur Americans (Formerly the Jerome Group)
FDA 510(k) clearance K071173 for RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D, Substantially Equivalent on 2007-05-25. Applicant: Ossur Americans (Formerly the Jerome Group).
Clearance details
- Applicant
- Ossur Americans (Formerly the Jerome Group)
- Product code
- Code HAX
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Paulsboro, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.