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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser For Gastro-Urology Use
510(k) Number K850728
Device Name MODEL 4000 ND:YAG LASER FOR GASTROINTESTIONAL BLEE
Applicant
Cooper Lasersonics, Inc.
3420 Central Expy. .
Santa Clara,  CA  95051
Applicant Contact CHARLES L ROSE
Correspondent
Cooper Lasersonics, Inc.
3420 Central Expy. .
Santa Clara,  CA  95051
Correspondent Contact CHARLES L ROSE
Regulation Number878.4810
Classification Product Code
LNK  
Date Received02/22/1985
Decision Date 04/08/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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