FDA 510(k) Application Details - K990175

Device Classification Name Transducer, Ultrasonic, Diagnostic

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510(K) Number K990175
Device Name Transducer, Ultrasonic, Diagnostic
Applicant SHEATHING TECHNOLOGIES, INC.
334 COMMERCIAL ST.
SAN JOSE, CA 95112 US
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Contact LAWRENCE S POLAYES
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Regulation Number 892.1570

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Classification Product Code ITX
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Date Received 01/19/1999
Decision Date 04/21/1999
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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