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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tampon, menstrual, unscented
510(k) Number K023789
Device Name O.B. TAMPONS
Applicant
MCNEIL-PPC, INC.
199 GRANDVIEW RD.
SKILLMAN,  NJ  08558
Applicant Contact DIANA L.B. UHL
Correspondent
MCNEIL-PPC, INC.
199 GRANDVIEW RD.
SKILLMAN,  NJ  08558
Correspondent Contact DIANA L.B. UHL
Regulation Number884.5470
Classification Product Code
HEB  
Date Received11/13/2002
Decision Date 12/06/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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