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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Breast, Powered
510(k) Number K895114
Device Name FRANK MILK PUMP
Applicant
Buttner-Frank GmbH
8520 Erlangen-Tennenlohe
Am Wolfsmantel 9/Gewerbegabiet
Postfach 1266,  DE
Applicant Contact BLANK
Correspondent
Buttner-Frank GmbH
8520 Erlangen-Tennenlohe
Am Wolfsmantel 9/Gewerbegabiet
Postfach 1266,  DE
Correspondent Contact BLANK
Regulation Number884.5160
Classification Product Code
HGX  
Date Received08/15/1989
Decision Date 03/05/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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