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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K030518
Device Name AMERITEK SURE-POINT TRACKER SYSTEM
Applicant
Amertek Medical, Inc.
2655 N. Ocean Dr. #405
Singer Island,  FL  33404
Applicant Contact GREG WIITA
Correspondent
Amertek Medical, Inc.
2655 N. Ocean Dr. #405
Singer Island,  FL  33404
Correspondent Contact GREG WIITA
Regulation Number892.1570
Classification Product Code
ITX  
Date Received02/19/2003
Decision Date 05/20/2003
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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