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FDA 510(k), K081589, WATERLASE, VERSION 3.0
FDA 510(k), K081589, WATERLASE, VERSION 3.0
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$49.00 USD
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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
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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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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