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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Ent Microsurgical Carbon-Dioxide
510(k) Number K870587
Device Name LASERMATIC SURGILASER MODEL 5050
Applicant
LASERMATIC OY
LEPOLANTIE 21
SF-00660 HELSINKI
FINLAND,  FI
Applicant Contact ESA VIHERKOSKI
Correspondent
LASERMATIC OY
LEPOLANTIE 21
SF-00660 HELSINKI
FINLAND,  FI
Correspondent Contact ESA VIHERKOSKI
Regulation Number874.4500
Classification Product Code
EWG  
Date Received02/10/1987
Decision Date 08/10/1988
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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