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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 K080775
Device Name MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS
Applicant
Tosama D.D.
Saranoviceva Cesta 035
Vir, Domzale,  SI 1230
Applicant Contact ANTONIJA VIDENSEK
Correspondent
Kema Quality B.V.
4377 County Line Rd.
Chalfont,  PA  18914
Correspondent Contact HARRY VAN VUGT
Regulation Number884.5470
Classification Product Code
HEB  
Date Received03/19/2008
Decision Date 09/10/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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