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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 K911238
Device Name TAHOE SUCTION IRRIGATOR
Applicant
Tahoe Pro Instruments
P.O. Box 612617
So. Lake Tahoe,  CA  95761
Applicant Contact GARY WILLEN
Correspondent
Tahoe Pro Instruments
P.O. Box 612617
So. Lake Tahoe,  CA  95761
Correspondent Contact GARY WILLEN
Regulation Number880.6740
Classification Product Code
GCX  
Date Received03/20/1991
Decision Date 11/27/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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