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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image-Intensified Fluoroscopic X-Ray System, Mobile
510(k) Number K993092
Device Name SONADA ULTRASOUND SYSTEM
Applicant
SONOVISION CORP.
377 ROUTE 17 SOUTH
SUITE 204
HASBROUCK HEIGHTS,  NJ  07604
Applicant Contact PAUL SCHNEIDER
Correspondent
SONOVISION CORP.
377 ROUTE 17 SOUTH
SUITE 204
HASBROUCK HEIGHTS,  NJ  07604
Correspondent Contact PAUL SCHNEIDER
Regulation Number892.1650
Classification Product Code
OXO  
Date Received09/16/1999
Decision Date 04/14/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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