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FDA 510(k) Application Details - K973936
Device Classification Name
Accelerator, Linear, Medical
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510(K) Number
K973936
Device Name
Accelerator, Linear, Medical
Applicant
COMPUTERIZED MEDICAL SYSTEMS, INC.
1195 CORPORATE LAKE DR.
ST. LOUIS, MO 63132-1716 US
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Contact
MICHAEL A PARSONS
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Regulation Number
892.5050
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Classification Product Code
IYE
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More FDA Info for this Product Code
Date Received
10/15/1997
Decision Date
06/01/1998
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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