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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K970787
Device Name ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3)
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 Number870.2340
Classification Product Code
DPS  
Date Received03/04/1997
Decision Date 05/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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