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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 K042752
Device Name ACCUPACH V
Applicant
Accutome Ultrasound, Inc.
263 Great Valley Pkwy.
Malvern,  PA  19355
Applicant Contact JEFFREY L WRIGHT
Correspondent
Accutome Ultrasound, Inc.
263 Great Valley Pkwy.
Malvern,  PA  19355
Correspondent Contact JEFFREY L WRIGHT
Regulation Number892.1560
Classification Product Code
IYO  
Date Received10/04/2004
Decision Date 11/10/2004
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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