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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 K120234
Device Name EZONO 3000
Applicant
Life-Tech, Inc.
13235 N Promenade Blvd.
Stafford,  TX  77477
Applicant Contact SKIP RIMER
Correspondent
Life-Tech, Inc.
13235 N Promenade Blvd.
Stafford,  TX  77477
Correspondent Contact SKIP RIMER
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received01/25/2012
Decision Date 04/19/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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