PH BUFFERING PLASTIC APPLICATOR TAMPON

Tampon, Menstrual, Unscented

ROSTAM LTD.

The following data is part of a premarket notification filed by Rostam Ltd. with the FDA for Ph Buffering Plastic Applicator Tampon.

Pre-market Notification Details

Device IDK030474
510k NumberK030474
Device Name:PH BUFFERING PLASTIC APPLICATOR TAMPON
ClassificationTampon, Menstrual, Unscented
Applicant ROSTAM LTD. 555 13TH ST. NW Washington,  DC  20004 -1109
ContactJonathan S Kahan
CorrespondentJonathan S Kahan
ROSTAM LTD. 555 13TH ST. NW Washington,  DC  20004 -1109
Product CodeHEB  
CFR Regulation Number884.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2003-02-12
Decision Date2004-05-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10050428534608 K030474 000

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