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FDA 510(k) Application Details - K971234
Device Classification Name
Accessories, Pump, Infusion
More FDA Info for this Device
510(K) Number
K971234
Device Name
Accessories, Pump, Infusion
Applicant
ALEXANDER MFG. CO.
1511 S GARFIELD PL
MASON CITY, IA 50401 US
Other 510(k) Applications for this Company
Contact
KEN HEIMENDINGER
Other 510(k) Applications for this Contact
Regulation Number
880.5725
More FDA Info for this Regulation Number
Classification Product Code
MRZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/02/1997
Decision Date
05/27/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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