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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pad, Menstrual, Unscented
510(k) Number K951693
Device Name CARESS SANITARY NAPKIN
Applicant
Sterling U.S.A., Inc.
90 Ronzo Rd.
Bristol,  CT  06010
Applicant Contact CAROL FOSTER
Correspondent
Sterling U.S.A., Inc.
90 Ronzo Rd.
Bristol,  CT  06010
Correspondent Contact CAROL FOSTER
Regulation Number884.5435
Classification Product Code
HHD  
Date Received04/12/1995
Decision Date 07/25/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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