FDA 510(k), K081589, WATERLASE, VERSION 3.0

FDA 510(k), K081589, WATERLASE, VERSION 3.0

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510(K) Number: K081589
Device Name: WATERLASE, VERSION 3.0
Manufacturer: BIOLASE TECHNOLOGY, INC.
Device Classification Name: powered laser surgical instrument
Regulation Number: 878.4810
Classification Product Code: GEX
Date Received: 06/05/2008
Decision Date: 06/13/2008
Regulation Medical Specialty: General & Plastic Surgery

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