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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 K080975
Device Name FENCER 308 EXCIMER LASER SYSTEM
Applicant
Kera Harvest/Laser Max Medical Technologies Corp
1601 N. Clancy St.
Visalia,  CA  93291 -9263
Applicant Contact PAUL Y FANG
Correspondent
Kera Harvest/Laser Max Medical Technologies Corp
1601 N. Clancy St.
Visalia,  CA  93291 -9263
Correspondent Contact PAUL Y FANG
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/07/2008
Decision Date 07/15/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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