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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 K022140
Device Name WHISPER WEAR BREAST PUMP
Applicant
Whisper Wear
19526 E. Lake Dr.
Miami,  FL  33015
Applicant Contact AL WEISENBORN
Correspondent
Whisper Wear
19526 E. Lake Dr.
Miami,  FL  33015
Correspondent Contact AL WEISENBORN
Regulation Number884.5160
Classification Product Code
HGX  
Date Received07/02/2002
Decision Date 09/30/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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