The following data is part of a premarket notification filed by Rostam Ltd. with the FDA for Tampons.
| Device ID | K001641 |
| 510k Number | K001641 |
| Device Name: | TAMPONS |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | ROSTAM LTD. 73 FRANKLIN TPK. Allendale, NJ 07401 |
| Contact | Robert J Staab |
| Correspondent | Robert J Staab ROSTAM LTD. 73 FRANKLIN TPK. Allendale, NJ 07401 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-30 |
| Decision Date | 2000-08-03 |