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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 K950531
Device Name EGNELL ELITE
Applicant
Hollister, Inc.
755 Industrial Dr.
Cary,  IL  60013
Applicant Contact ROLAND MULLER
Correspondent
Hollister, Inc.
755 Industrial Dr.
Cary,  IL  60013
Correspondent Contact ROLAND MULLER
Regulation Number884.5160
Classification Product Code
HGX  
Date Received02/07/1995
Decision Date 09/22/1995
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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