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FDA 510(k), K011041, WATERLASE, MILLENNIUM
FDA 510(k), K011041, WATERLASE, MILLENNIUM
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510(K) Number: K011041
Device Name: WATERLASE, MILLENNIUM
Manufacturer: IOANA M RIZOIU
Device Classification Name: Powered Laser Surgical Instrument
Regulation Number: GEX
Classification Product Code: KXA
Date Received: 04/05/2001
Decision Date: 07/03/2001
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: WATERLASE, MILLENNIUM
Manufacturer: IOANA M RIZOIU
Device Classification Name: Powered Laser Surgical Instrument
Regulation Number: GEX
Classification Product Code: KXA
Date Received: 04/05/2001
Decision Date: 07/03/2001
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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