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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 K972746
Device Name ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP6/100
Applicant
Alexander Mfg. Co.
1511 S Garfield Pl
Mason City,  IA  50401
Applicant Contact KEN HEIMENDINGER
Correspondent
Alexander Mfg. Co.
1511 S Garfield Pl
Mason City,  IA  50401
Correspondent Contact KEN HEIMENDINGER
Regulation Number870.2340
Classification Product Code
DPS  
Date Received07/23/1997
Decision Date 10/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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