The following data is part of a premarket notification filed by Rostam Ltd. with the FDA for Rostam Scented And Unscented Biodegradable Plastic Applicator Tampons.
| Device ID | K102445 |
| 510k Number | K102445 |
| Device Name: | ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE 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 | 2010-08-26 |
| Decision Date | 2010-11-10 |
| Summary: | summary |