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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 K020535
Device Name INTERLUDE AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS
Applicant
ROSTAM LTD.
73 FRANKLIN TPK.
ALLENDALE,  NJ  07401
Applicant Contact ROBERT J STAAB
Correspondent
ROSTAM LTD.
73 FRANKLIN TPK.
ALLENDALE,  NJ  07401
Correspondent Contact ROBERT J STAAB
Regulation Number884.5470
Classification Product Code
HEB  
Date Received02/19/2002
Decision Date 05/09/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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