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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 Echo, Ultrasonic
510(k) Number K982800
Device Name ECTON LYNX ULTRASOUND SYSTEM
Applicant
Ecton, Inc.
110 W. Butler Ave., #100
Ambler,  PA  19002 -9998
Applicant Contact CHRISTOPHER B KNELL
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462 -1298
Regulation Number892.1560
Classification Product Code
IYO  
Date Received08/10/1998
Decision Date 09/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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