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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 K081047
Device Name TRANSPOSAL ULTRA SYSTEMS
Applicant
DORNOCH MEDICAL SYSTEMS, INC.
4032 WEST RIVERSIDE ST.
RIVERSIDE,  MO  64150
Applicant Contact ANTHONY MARTINI
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number878.4780
Classification Product Code
JCX  
Date Received04/14/2008
Decision Date 04/29/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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