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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, ward use, portable, ac-powered
510(k) Number K133786
Device Name DORNOCH DUO SUCTION CART WITH: DL2800 LID, CL500 LID, DORNOCH QUAD SUCTION CART WITH: DL2800 LID, CL500 LID
Applicant
DORNOCH MEDICAL SYSTEMS, INC.
200 Nw Parkway Rd
RIVERSIDE,  MO  64150
Applicant Contact LARRY SMITH
Correspondent
DORNOCH MEDICAL SYSTEMS, INC.
200 Nw Parkway Rd
RIVERSIDE,  MO  64150
Correspondent Contact LARRY SMITH
Regulation Number878.4780
Classification Product Code
JCX  
Date Received12/12/2013
Decision Date 03/21/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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