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FDA 510(k), K080376, ONCOBIONIC SYSTEM
FDA 510(k), K080376, ONCOBIONIC SYSTEM
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510(K) Number: K080376
Device Name: ONCOBIONIC SYSTEM
Manufacturer: ONCOBIONIC INCORPORATED
Device Classification Name: low energy direct current thermal ablation system
Regulation Number: 878.4400
Classification Product Code: OAB
Date Received: 02/12/2008
Decision Date: 04/02/2008
Regulation Medical Specialty: General & Plastic Surgery
Device Name: ONCOBIONIC SYSTEM
Manufacturer: ONCOBIONIC INCORPORATED
Device Classification Name: low energy direct current thermal ablation system
Regulation Number: 878.4400
Classification Product Code: OAB
Date Received: 02/12/2008
Decision Date: 04/02/2008
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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