The following data is part of a premarket notification filed by Rostam Ltd. with the FDA for Interlude And Other Private Label Plastic Applicator Tampons.
| Device ID | K020535 |
| 510k Number | K020535 |
| Device Name: | INTERLUDE AND OTHER PRIVATE LABEL PLASTIC APPLICATOR 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 | 2002-02-19 |
| Decision Date | 2002-05-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10400265047203 | K020535 | 000 |
| 10050428355852 | K020535 | 000 |
| 10050428352790 | K020535 | 000 |
| 10050428340773 | K020535 | 000 |
| 10050428286392 | K020535 | 000 |
| 10050428267995 | K020535 | 000 |
| 10049022632834 | K020535 | 000 |
| 10049022632827 | K020535 | 000 |
| 10883967418371 | K020535 | 000 |
| 10036800426679 | K020535 | 000 |
| 10050428398477 | K020535 | 000 |
| 10050428410704 | K020535 | 000 |
| 10400265047128 | K020535 | 000 |
| 10635515992495 | K020535 | 000 |
| 10635515992488 | K020535 | 000 |
| 10681131068311 | K020535 | 000 |
| 10681131068304 | K020535 | 000 |
| 10681131068298 | K020535 | 000 |
| 10681131068281 | K020535 | 000 |
| 10719283091830 | K020535 | 000 |
| 10050428434809 | K020535 | 000 |
| 10036800426709 | K020535 | 000 |