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FDA 510(k) Application Details - K982463
Device Classification Name
Accelerator, Linear, Medical
More FDA Info for this Device
510(K) Number
K982463
Device Name
Accelerator, Linear, Medical
Applicant
HOWMEDICA, INC.
359 VETERANS BLVD.
RUTHERFORD, NJ 07070-2584 US
Other 510(k) Applications for this Company
Contact
VIVIAN KELLY
Other 510(k) Applications for this Contact
Regulation Number
892.5050
More FDA Info for this Regulation Number
Classification Product Code
IYE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/15/1998
Decision Date
09/30/1998
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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