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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 K864413
Device Name MODEL HSE-5M MICROWAVE SURGERY EQUIPMENT/MICROTAZE
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 Number876.4300
Classification Product Code
KNS  
Date Received11/10/1986
Decision Date 12/09/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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