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 |