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FDA 510(k), K071328, VISUALASE THERMAL THERAPY SYSTEM
FDA 510(k), K071328, VISUALASE THERMAL THERAPY SYSTEM
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510(K) Number: K071328
Device Name: VISUALASE THERMAL THERAPY SYSTEM
Manufacturer: BIOTEX, INC.
Device Classification Name: powered laser surgical instrument
Regulation Number: 878.4810
Classification Product Code: GEX
Date Received: 05/11/2007
Decision Date: 08/31/2007
Regulation Medical Specialty: General & Plastic Surgery
Device Name: VISUALASE THERMAL THERAPY SYSTEM
Manufacturer: BIOTEX, INC.
Device Classification Name: powered laser surgical instrument
Regulation Number: 878.4810
Classification Product Code: GEX
Date Received: 05/11/2007
Decision Date: 08/31/2007
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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