The following data is part of a premarket notification filed by Rostam Ltd. with the FDA for Rostam Ltd. Fragranced Or Unfragranced New Plastic Applicator Tampons.
| Device ID | K090071 |
| 510k Number | K090071 |
| Device Name: | ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | ROSTAM LTD. 30 NECK ROAD Old Lyme, CT 06371 |
| Contact | Robert J Staab |
| Correspondent | Robert J Staab ROSTAM LTD. 30 NECK ROAD Old Lyme, CT 06371 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-12 |
| Decision Date | 2009-05-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00400265047046 | K090071 | 000 |
| 10050428400781 | K090071 | 000 |
| 10050428299941 | K090071 | 000 |
| 10050428293406 | K090071 | 000 |
| 10050428255121 | K090071 | 000 |
| 10049022632810 | K090071 | 000 |
| 10049022607900 | K090071 | 000 |
| 10049022607894 | K090071 | 000 |
| 10883967418357 | K090071 | 000 |
| 07290016625554 | K090071 | 000 |
| 07290016625547 | K090071 | 000 |
| 07290016625530 | K090071 | 000 |
| 10036800426693 | K090071 | 000 |
| 10050428410988 | K090071 | 000 |
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| 10400265046961 | K090071 | 000 |
| 10635515995489 | K090071 | 000 |
| 10635515995465 | K090071 | 000 |
| 10614299407203 | K090071 | 000 |
| 10614299407166 | K090071 | 000 |
| 10681131027172 | K090071 | 000 |
| 10681131027165 | K090071 | 000 |
| 10719283091823 | K090071 | 000 |
| 10072036722741 | K090071 | 000 |
| 10072036722734 | K090071 | 000 |
| 10070038651403 | K090071 | 000 |
| 10070038651397 | K090071 | 000 |
| 10036800426686 | K090071 | 000 |