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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 K043588
Device Name MYLAB 15 / MYLAB 20, MODEL 2700
Applicant
Pie Medical
7992 Castleway Dr.
Indianpolis,  IN  46250
Applicant Contact CARRI GRAHAM
Correspondent
Pie Medical
7992 Castleway Dr.
Indianpolis,  IN  46250
Correspondent Contact CARRI GRAHAM
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received12/28/2004
Decision Date 01/25/2005
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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