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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thermometer, Electronic, Clinical
510(k) Number K970271
Device Name ALEXANDER MANUFACTURING COMPANY
Applicant
ALEXANDER MFG. CO.
1511 S GARFIELD PL
MASON CITY,  IA  50401
Applicant Contact STACEY HIPPEN
Correspondent
ALEXANDER MFG. CO.
1511 S GARFIELD PL
MASON CITY,  IA  50401
Correspondent Contact STACEY HIPPEN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received01/23/1997
Decision Date 04/02/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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