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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 K930400
Device Name TERRA FEMME
Applicant
BIO BUSINESS INTL, INC.
152 LAMBERTLODGE AVENUE
CANADA M6G 3X3,  CA
Applicant Contact WILHELMINA NOLAN
Correspondent
BIO BUSINESS INTL, INC.
152 LAMBERTLODGE AVENUE
CANADA M6G 3X3,  CA
Correspondent Contact WILHELMINA NOLAN
Regulation Number884.5470
Classification Product Code
HEB  
Date Received01/26/1993
Decision Date 03/14/1994
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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