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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 K974880
Device Name PERCEPTION GPS-RST DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
Perception, Inc.
55 Northern Blvd., Suite 410
Great Neck,,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
Perception, Inc.
55 Northern Blvd., Suite 410
Great Neck,,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
IYN  
Date Received12/30/1997
Decision Date 06/08/1998
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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