The following data is part of a premarket notification filed by Rostam Ltd. with the FDA for Rostam Scented And Unscented Plastic Applicator Tampons.
| Device ID | K062001 |
| 510k Number | K062001 |
| Device Name: | ROSTAM SCENTED AND UNSCENTED 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 | 2006-07-14 |
| Decision Date | 2006-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10070552250113 | K062001 | 000 |
| 10050428258795 | K062001 | 000 |
| 10834533004764 | K062001 | 000 |