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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 K051876
Device Name MULTIWAVE XR
Applicant
Pacific Quantum Instruments, Inc.
408 Bryant Circle, Suite F-1
Ojai,  CA  93023
Applicant Contact GENNADY L NIKOLAENKO
Correspondent
Pacific Quantum Instruments, Inc.
408 Bryant Circle, Suite F-1
Ojai,  CA  93023
Correspondent Contact GENNADY L NIKOLAENKO
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/11/2005
Decision Date 09/09/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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