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FDA 510(k) Application Details - K964952
Device Classification Name
System, Therapeutic, X-Ray
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510(K) Number
K964952
Device Name
System, Therapeutic, X-Ray
Applicant
VICTOREEN, INC.
6000 COCHRAN RD.
CLEVELAND, OH 44130-3304 US
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Contact
LINDA S MORIN
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Regulation Number
892.5900
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Classification Product Code
JAD
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More FDA Info for this Product Code
Date Received
12/10/1996
Decision Date
07/21/1997
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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