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FDA 510(k) Application Details - K993092
Device Classification Name
More FDA Info for this Device
510(K) Number
K993092
Device Name
SONADA ULTRASOUND SYSTEM
Applicant
SONOVISION CORP.
377 ROUTE 17 SOUTH
SUITE 204
HASBROUCK HEIGHTS, NJ 07604 US
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Contact
PAUL SCHNEIDER
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
OXO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/16/1999
Decision Date
04/14/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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