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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 K090071
Device Name ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS
Applicant
ROSTAM LTD.
30 NECK ROAD
OLD LYME,  CT  06371
Applicant Contact ROBERT J STAAB
Correspondent
ROSTAM LTD.
30 NECK ROAD
OLD LYME,  CT  06371
Correspondent Contact ROBERT J STAAB
Regulation Number884.5470
Classification Product Code
HEB  
Subsequent Product Code
HIL  
Date Received01/12/2009
Decision Date 05/28/2009
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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