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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 K954942
Device Name NATRACAREN APPLICATOR TAMPON
Applicant
BODYWISE (UK), LTD.
14 LOWER COURT RD.
LOWER ALMONDSBURY
BRISTOL, AVON,  GB BS32 4DX
Applicant Contact S. P. HEWSON
Correspondent
BODYWISE (UK), LTD.
14 LOWER COURT RD.
LOWER ALMONDSBURY
BRISTOL, AVON,  GB BS32 4DX
Correspondent Contact S. P. HEWSON
Regulation Number884.5470
Classification Product Code
HEB  
Date Received10/30/1995
Decision Date 01/25/1996
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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