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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Coupling, Ultrasound
510(k) Number K030889
Device Name ULTRAEKOGEL MODELS EK 2000 & EK 2001
Applicant
Inmed Ltda.
1308 Morningside Park Dr.
Alpharetta,  GA  30022
Applicant Contact JAY MANSOUR
Correspondent
Inmed Ltda.
1308 Morningside Park Dr.
Alpharetta,  GA  30022
Correspondent Contact JAY MANSOUR
Regulation Number892.1570
Classification Product Code
MUI  
Date Received03/21/2003
Decision Date 05/23/2003
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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