FDA 510(k) Application Details - K052067

Device Classification Name Monitor, Ultrasonic, Nonfetal

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510(K) Number K052067
Device Name Monitor, Ultrasonic, Nonfetal
Applicant MULTIGON INDUSTRIES, INC.
ONE ODELL PLAZA
YONKERS, NY 10701 US
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Contact WILLIAM STERN
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Regulation Number 892.1540

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Classification Product Code JAF
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Date Received 08/01/2005
Decision Date 08/29/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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