The following data is part of a premarket notification filed by Albaad Fem with the FDA for Interlude Rolled Tampons In Plastic Applicator.
| Device ID | K191431 |
| 510k Number | K191431 |
| Device Name: | Interlude Rolled Tampons In Plastic Applicator |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | ALBAAD Fem 1, Alon Hatavor St. Caesarea Ind. Park, IL 3088900 |
| Contact | Shlomo Helvits |
| Correspondent | Robert. J. Staab Regulatory Technical Associates 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 | 2019-05-29 |
| Decision Date | 2019-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850373007041 | K191431 | 000 |
| 00810027130709 | K191431 | 000 |
| 00810027130693 | K191431 | 000 |