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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 K965064
Device Name ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON
Applicant
Rostam , Ltd.
7310 W 100 N.
Greenfield,  IN  46140
Applicant Contact DONNA GALERMAN
Correspondent
Rostam , Ltd.
7310 W 100 N.
Greenfield,  IN  46140
Correspondent Contact DONNA GALERMAN
Regulation Number884.5470
Classification Product Code
HEB  
Date Received12/18/1996
Decision Date 02/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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