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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shield, Nipple
510(k) Number K944117
Device Name AVENT NIPPLE SHIELD
Applicant
Avent America, Inc.
1765 W. Cortland Ct., Unit L
Addison,  IL  60101
Correspondent
Avent America, Inc.
1765 W. Cortland Ct., Unit L
Addison,  IL  60101
Regulation Number880.5630
Classification Product Code
HFS  
Date Received08/23/1994
Decision Date 10/05/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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