FDA 510(k) Application Details - K993092

Device Classification Name

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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
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Regulation Number

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Classification Product Code OXO
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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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