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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bronchoscope (flexible or rigid)
510(k) Number K862835
Device Name CO2 FIBEROPTIC DELIVERY SYSTEM/BRONCHOSCOPIC USE
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 Number874.4680
Classification Product Code
EOQ  
Date Received07/25/1986
Decision Date 02/05/1987
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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