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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name unit, electrosurgical, endoscopic (with or without accessories)
510(k) Number K861904
Device Name HS-15M MICROWAVE SURGERY EQUIPMENT, MICROTAZE
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 Number876.4300
Classification Product Code
KNS  
Date Received05/16/1986
Decision Date 10/16/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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