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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, non-powered
510(k) Number K952035
Device Name NIPLETTE
Applicant
AVENT AMERICA, INC.
1765 W. CORTLAND COURT, UNIT L
ADDISON,  IL  60101
Applicant Contact ELIZABETH IVERSON
Correspondent
AVENT AMERICA, INC.
1765 W. CORTLAND COURT, UNIT L
ADDISON,  IL  60101
Correspondent Contact ELIZABETH IVERSON
Regulation Number884.5150
Classification Product Code
HGY  
Date Received05/01/1995
Decision Date 07/28/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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