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FDA 510(k) Application Details - K992178
Device Classification Name
Transducer, Ultrasonic, Diagnostic
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510(K) Number
K992178
Device Name
Transducer, Ultrasonic, Diagnostic
Applicant
N.M. BEALE CO. INC.
89 OLD SHIRLEY RD.
HARVARD, MA 01451 US
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Contact
NATHANIEL M BEALE
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Regulation Number
892.1570
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Classification Product Code
ITX
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More FDA Info for this Product Code
Date Received
06/28/1999
Decision Date
05/12/2000
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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