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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 K861608
Device Name UNICARE BREAST SHELLS
Applicant
Unicare Medical Products, Inc.
119 Montee De Liesse,
Montreal
Quebec H4t 1s6,  CA
Correspondent
Unicare Medical Products, Inc.
119 Montee De Liesse,
Montreal
Quebec H4t 1s6,  CA
Regulation Number880.5630
Classification Product Code
HFS  
Date Received04/29/1986
Decision Date 07/15/1986
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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