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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 K833450
Device Name NUK BREAST SHIELD
Applicant
Reliance Products Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Reliance Products Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5630
Classification Product Code
HFS  
Date Received10/05/1983
Decision Date 11/21/1983
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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