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FDA 510(k) Application Details - K973644
Device Classification Name
Monitor, Ultrasonic, Nonfetal
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510(K) Number
K973644
Device Name
Monitor, Ultrasonic, Nonfetal
Applicant
BIOMEDIX, INC.
P.O. BOX 1419
CAMDEN, NJ 08105 US
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DAVID LERNER
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Regulation Number
892.1540
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Classification Product Code
JAF
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Date Received
09/24/1997
Decision Date
12/23/1997
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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