OPTISOURCE, MODEL 1032P— 510(k) K040766
Substantially EquivalentInternational Brachytherapy S.A.
FDA 510(k) clearance K040766 for OPTISOURCE, MODEL 1032P, Substantially Equivalent on 2004-07-22. Applicant: International Brachytherapy S.A.. Device class: 2.
Clearance details
- Applicant
- International Brachytherapy S.A.
- Product code
- Code KXK
- Device class
- Class 2
- Regulation
- 21 CFR 892.5730
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Norcross, GA, US
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