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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 K861903
Device Name #6000 ND:YAG LASER SYSTEM UROLOGY/GASTROINTESTINAL
Applicant
COOPER LASERSONICS, INC.
3420 Central Expressway
Santa Clara,  CA  95051
Applicant Contact CHARLES ROSE
Correspondent
COOPER LASERSONICS, INC.
3420 Central Expressway
Santa Clara,  CA  95051
Correspondent Contact CHARLES ROSE
Regulation Number878.4810
Classification Product Code
LNK  
Date Received05/16/1986
Decision Date 06/20/1986
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
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