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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 K162421
Device Name IntelliCartTM System
Applicant
DORNOCH MEDICAL SYSTEMS
200 NW PARKWAY
RIVERSIDE,  MO  64150
Applicant Contact LARRY SMITH
Correspondent
DORNOCH MEDICAL SYSTEMS
200 NW PARKWAY
RIVERSIDE,  MO  64150
Correspondent Contact MICHAEL WOLFORD
Regulation Number878.4780
Classification Product Code
JCX  
Date Received08/30/2016
Decision Date 12/21/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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