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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 K944177
Device Name BREAST SHELL
Applicant
O'Donnell, Byrne & Williams
20 N. Wacker Dr.
Suite 3710
Chicago,  IL  60606
Applicant Contact KEVIN WILLIAMS
Correspondent
O'Donnell, Byrne & Williams
20 N. Wacker Dr.
Suite 3710
Chicago,  IL  60606
Correspondent Contact KEVIN WILLIAMS
Regulation Number880.5630
Classification Product Code
HFS  
Date Received08/26/1994
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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