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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, scented, deodorized
510(k) Number K042773
Device Name ROSTAM SCENTED AND UNSCENTED 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 Number884.5460
Classification Product Code
HIL  
Subsequent Product Code
HEB  
Date Received10/05/2004
Decision Date 11/23/2004
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
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