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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K090281
Device Name ACCUTECH FAMILY OF POWERFLEX LASER DELIVERY DEVICES
Applicant
ACCUTECH MEDICAL TECHNOLOGIES, INC.
3637 BERNAL AVE
PLEASANTON,  CA  94566
Applicant Contact ANNE WORDEN
Correspondent
ACCUTECH MEDICAL TECHNOLOGIES, INC.
3637 BERNAL AVE
PLEASANTON,  CA  94566
Correspondent Contact ANNE WORDEN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/05/2009
Decision Date 03/04/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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