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510(k) Premarket Notification Database

Device Classification Name thermometer, electronic, clinical
510(k) NumberK970271
Device NameALEXANDER MANUFACTURING COMPANY
Applicant
ALEXANDER MFG. CO.
1511 s garfield pl
mason city,  IA  50401
Contactstacey hippen
Regulation Number880.2910
Classification Product Code
FLL
Date Received01/23/1997
Decision Date 04/02/1997
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Statement/Summary/Purged Status Statement only
Type Traditional
Reviewed by Third Party No
Expedited Review No

Database Updated 01/16/2009

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