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FDA 510(k), K110225, ANGIODYNAMICS, INC. VENACURE 1470 LASER
FDA 510(k), K110225, ANGIODYNAMICS, INC. VENACURE 1470 LASER
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510(K) Number: K110225
Device Name: ANGIODYNAMICS, INC. VENACURE 1470 LASER
Manufacturer: TERI JUCKETT
Device Classification Name: Powered Laser Surgical Instrument
Regulation Number: GEX
Classification Product Code: KXA
Date Received: 01/25/2011
Decision Date: 05/13/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: ANGIODYNAMICS, INC. VENACURE 1470 LASER
Manufacturer: TERI JUCKETT
Device Classification Name: Powered Laser Surgical Instrument
Regulation Number: GEX
Classification Product Code: KXA
Date Received: 01/25/2011
Decision Date: 05/13/2011
Decision: Substantially Equivalent (SESE)
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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