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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 K034011
Device Name GEMINI SURGICAL LASER SYSTEM & ACCESSORIES
Applicant
Laserscope
3070 Orchard Dr.
San Jose,  CA  95134 -2011
Applicant Contact PAUL HARDIMAN
Correspondent
Laserscope
3070 Orchard Dr.
San Jose,  CA  95134 -2011
Correspondent Contact PAUL HARDIMAN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/24/2003
Decision Date 03/30/2004
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
Predetermined Change
Control Plan Authorized		 No
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