The following data is part of a premarket notification filed by Rostam Ltd. with the FDA for Rostam Applicator Tampon/rostam Non Applicator Tampon.
| Device ID | K965064 |
| 510k Number | K965064 |
| Device Name: | ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | ROSTAM LTD. 7310 W 100 N. Greenfield, IN 46140 -8385 |
| Contact | Donna Galerman |
| Correspondent | Donna Galerman ROSTAM LTD. 7310 W 100 N. Greenfield, IN 46140 -8385 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-18 |
| Decision Date | 1997-02-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00834533001308 | K965064 | 000 |
| 10195515003411 | K965064 | 000 |
| 10075289039000 | K965064 | 000 |