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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Pressure, Intrauterine
510(k) Number K973850
Device Name ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007
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 Number884.2700
Classification Product Code
HFO  
Subsequent Product Code
HGM  
Date Received10/08/1997
Decision Date 11/12/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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