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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 K912753
Device Name XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL
Applicant
Xomed-Treace, Inc.
6743 Southpoint Dr. N.
Jacksonville,  FL  32216
Applicant Contact TERRY C MCMAHON
Correspondent
Xomed-Treace, Inc.
6743 Southpoint Dr. N.
Jacksonville,  FL  32216
Correspondent Contact TERRY C MCMAHON
Regulation Number880.6740
Classification Product Code
GCX  
Date Received06/24/1991
Decision Date 09/23/1991
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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