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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Suction, Operating-Room, Wall Vacuum Powered
510(k) Number K992126
Device Name CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM
Applicant
Circon Corp.
6500 Hollister Ave.
Santa Barbara,  CA  93117
Applicant Contact RONALD J EHMSEN
Correspondent
Circon Corp.
6500 Hollister Ave.
Santa Barbara,  CA  93117
Correspondent Contact RONALD J EHMSEN
Regulation Number880.6740
Classification Product Code
GCX  
Date Received06/23/1999
Decision Date 08/03/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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