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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 Rd.
Old Lyme,  CT  06371
Applicant Contact ROBERT J STAAB
Correspondent
Rostam , Ltd.
30 Neck Rd.
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
Predetermined Change
Control Plan Authorized		 No
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