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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 K880429
Device Name ILLUMINA 55 CO2 LASER SYSTEM
Applicant
COOPER LASERSONICS, INC.
3420 Central Expressway
Santa Clara,  CA  95051
Applicant Contact CHARLES L ROSE
Correspondent
COOPER LASERSONICS, INC.
3420 Central Expressway
Santa Clara,  CA  95051
Correspondent Contact CHARLES L ROSE
Regulation Number874.4500
Classification Product Code
EWG  
Date Received02/01/1988
Decision Date 04/18/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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