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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 K912941
Device Name TAMPON, UNTREATED
Applicant
HYGIEIA HEALTHCARE LTD.
RAINTON BRIDGE INDUS.ESTATE
HOUGHTON-LE-SPRING
TYNE AND WEAR, ENGLAND,  GB DH4 5PH
Applicant Contact BRENIKOV
Correspondent
HYGIEIA HEALTHCARE LTD.
RAINTON BRIDGE INDUS.ESTATE
HOUGHTON-LE-SPRING
TYNE AND WEAR, ENGLAND,  GB DH4 5PH
Correspondent Contact BRENIKOV
Regulation Number884.5470
Classification Product Code
HEB  
Date Received07/01/1991
Decision Date 03/06/1992
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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