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FDA 510(k) Application Details - K021124
Device Classification Name
Accelerator, Linear, Medical
More FDA Info for this Device
510(K) Number
K021124
Device Name
Accelerator, Linear, Medical
Applicant
WFR/AQUAPLAST CORP.
30 LAWLINS PARK
WYCKOFF, NJ 07481 US
Other 510(k) Applications for this Company
Contact
J DAMON KIRK
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
04/08/2002
Decision Date
07/02/2002
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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