The following data is part of a premarket notification filed by Albaad Ltd. with the FDA for Albaad Plastic Applicator Tampons Unscented.
| Device ID | K140077 |
| 510k Number | K140077 |
| Device Name: | ALBAAD PLASTIC APPLICATOR TAMPONS UNSCENTED |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | ALBAAD LTD. 30 NECK ROAD Old Lyme, CT 06371 |
| Contact | Robert J Staab, Ph.d. |
| Correspondent | Robert J Staab, Ph.d. ALBAAD 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 | 2014-01-13 |
| Decision Date | 2014-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10681131136157 | K140077 | 000 |
| 10834533000285 | K140077 | 000 |
| 10834533000964 | K140077 | 000 |
| 10834533000971 | K140077 | 000 |
| 10834533001145 | K140077 | 000 |
| 10883967418388 | K140077 | 000 |
| 10049022892085 | K140077 | 000 |
| 10049022892092 | K140077 | 000 |
| 10050428313203 | K140077 | 000 |
| 10050428345075 | K140077 | 000 |
| 10050428369057 | K140077 | 000 |
| 10050428392079 | K140077 | 000 |
| 10719283091793 | K140077 | 000 |
| 10719283091809 | K140077 | 000 |
| 10719283091816 | K140077 | 000 |
| 10834533000292 | K140077 | 000 |