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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 K022378
Device Name PLASMALITE PULSED LIGHT SYSTEM
Applicant
Medical Bio Care Sweden AB
908 Stetson St.
Woodland,  CA  95776
Applicant Contact CONNIE WHITE HOY
Correspondent
Medical Bio Care Sweden AB
908 Stetson St.
Woodland,  CA  95776
Correspondent Contact CONNIE WHITE HOY
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/22/2002
Decision Date 10/18/2002
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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