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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Infusion, Intravascular, Electronic
510(k) Number K971826
Device Name ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500
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 Number880.5725
Classification Product Code
LDR  
Date Received05/16/1997
Decision Date 07/03/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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