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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K043139
Device Name USCOM 1A
Applicant
Uscom, Ltd.
1700 Rockville Pike,Suite# 400
Rockville,  MD  20852
Applicant Contact CHRISTINA KICHULA
Correspondent
Uscom, Ltd.
1700 Rockville Pike,Suite# 400
Rockville,  MD  20852
Correspondent Contact CHRISTINA KICHULA
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
DSB   ITX  
Date Received11/12/2004
Decision Date 02/15/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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