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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 K954445
Device Name NON APPLICATOR TAMPON, UNTREATED
Applicant
HYGIEIA HEALTHCARE LTD.
UNIT 2 SUNRISE ENTERPRISE PARK
FERRYBOAT LANE
CASTLETOWN, SUNDERLAND SR5 3RX,  GB SR5 3RX
Applicant Contact PETER BRENIKOV
Correspondent
HYGIEIA HEALTHCARE LTD.
UNIT 2 SUNRISE ENTERPRISE PARK
FERRYBOAT LANE
CASTLETOWN, SUNDERLAND SR5 3RX,  GB SR5 3RX
Correspondent Contact PETER BRENIKOV
Regulation Number884.5470
Classification Product Code
HEB  
Date Received09/25/1995
Decision Date 02/12/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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