ONTEX AND OTHERS PROPRIETARY NAMES— 510(k) K132208
Substantially EquivalentOntex Bvba
FDA 510(k) clearance K132208 for ONTEX AND OTHERS PROPRIETARY NAMES, Substantially Equivalent on 2014-04-10. Applicant: Ontex Bvba. Device class: 2.
Clearance details
- Applicant
- Ontex Bvba
- Product code
- Code HIL
- Device class
- Class 2
- Regulation
- 21 CFR 884.5460
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- The Hague, NL
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More clearances from Ontex Bvba
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