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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Electric For Gravity Flow Infusion Systems
510(k) Number K972084
Device Name ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212
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 Number880.2420
Classification Product Code
FLN  
Date Received06/04/1997
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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