GELITA-SPON— 510(k) K051911
Substantially EquivalentCuramedical, BV
FDA 510(k) clearance K051911 for GELITA-SPON, Substantially Equivalent on 2005-12-06. Applicant: Curamedical, BV. Device class: 2.
Clearance details
- Applicant
- Curamedical, BV
- Product code
- Code KHJ
- Device class
- Class 2
- Regulation
- 21 CFR 874.3620
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Claremont, NH, US
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