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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 K935340
Device Name COMFORT PLUS NIPPLE SHIELDS
Applicant
Marshall Baby Products
300 Lakeview Pkwy.
Vernon Hills,  IL  60061
Applicant Contact JANE A EHRHARD
Correspondent
Marshall Baby Products
300 Lakeview Pkwy.
Vernon Hills,  IL  60061
Correspondent Contact JANE A EHRHARD
Regulation Number880.5630
Classification Product Code
HFS  
Date Received11/05/1993
Decision Date 01/21/1994
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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