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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 K962920
Device Name RENTON SUCTION DEVICE U.S. PATENT*4,767,404
Applicant
R&S SURGICAL, LLC.
107 TUNNEL HILL RD.
GEORGETOWN,  IN  47122
Applicant Contact DERRIC RENTON
Correspondent
R&S SURGICAL, LLC.
107 TUNNEL HILL RD.
GEORGETOWN,  IN  47122
Correspondent Contact DERRIC RENTON
Regulation Number880.6740
Classification Product Code
GCX  
Subsequent Product Code
JOL  
Date Received07/26/1996
Decision Date 10/21/1996
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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