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FDA 510(k) Application Details - K970738
Device Classification Name
System, X-Ray, Angiographic
More FDA Info for this Device
510(K) Number
K970738
Device Name
System, X-Ray, Angiographic
Applicant
JAMIESON FILM CO.
HEALTH SCIENCES DIVISION
901 ELMGROVE ROAD
ROCHESTER, NY 14653-5741 US
Other 510(k) Applications for this Company
Contact
DAN NEWMAN
Other 510(k) Applications for this Contact
Regulation Number
892.1600
More FDA Info for this Regulation Number
Classification Product Code
IZI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/28/1997
Decision Date
05/07/1997
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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