The following data is part of a premarket notification filed by Rostam Ltd. with the FDA for Ph Buffering Plastic Applicator Tampon.
Device ID | K030474 |
510k Number | K030474 |
Device Name: | PH BUFFERING PLASTIC APPLICATOR TAMPON |
Classification | Tampon, Menstrual, Unscented |
Applicant | ROSTAM LTD. 555 13TH ST. NW Washington, DC 20004 -1109 |
Contact | Jonathan S Kahan |
Correspondent | Jonathan S Kahan ROSTAM LTD. 555 13TH ST. NW Washington, DC 20004 -1109 |
Product Code | HEB |
CFR Regulation Number | 884.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2003-02-12 |
Decision Date | 2004-05-28 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10050428534608 | K030474 | 000 |