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FDA 510(k), K062963, PHAROS EXCIMER LASER SYSTEM, MODEL EX-308
FDA 510(k), K062963, PHAROS EXCIMER LASER SYSTEM, MODEL EX-308
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510(K) Number: K062963
Device Name: PHAROS EXCIMER LASER SYSTEM, MODEL EX-308
Manufacturer: DEAN IRWIN
Device Classification Name: Powered Laser Surgical Instrument
Regulation Number: GEX
Classification Product Code: 09/29/2006
Date Received: 04/03/2007
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: PHAROS EXCIMER LASER SYSTEM, MODEL EX-308
Manufacturer: DEAN IRWIN
Device Classification Name: Powered Laser Surgical Instrument
Regulation Number: GEX
Classification Product Code: 09/29/2006
Date Received: 04/03/2007
Decision Date: Substantially Equivalent (SESE)
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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