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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Neodymium:Yag, Pulmonary Surgery
510(k) Number K880170
Device Name MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS
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
LLO  
Date Received01/15/1988
Decision Date 03/24/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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