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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 K893225
Device Name COUPLANT WARMING DEVICE
Applicant
Echo Ultrasound
Post Office Box 552
Lewistown,  PA  17044
Applicant Contact DAVID SZCZUPAKOWSKI
Correspondent
Echo Ultrasound
Post Office Box 552
Lewistown,  PA  17044
Correspondent Contact DAVID SZCZUPAKOWSKI
Regulation Number892.1560
Classification Product Code
IYO  
Date Received04/27/1989
Decision Date 10/12/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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