The following data is part of a premarket notification filed by Calla Lily Personal Care, Ltd. with the FDA for Callaly Tampliner (super Plus Absorbency).
| Device ID | K212304 |
| 510k Number | K212304 |
| Device Name: | Callaly Tampliner (super Plus Absorbency) |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | Calla Lily Personal Care, Ltd. 10 Rose & Crown Yard London, GB Sw1y 6re |
| Contact | Shaun Knights |
| Correspondent | Kathleen Harris 2Harris Consulting, Ltd. 129 Blore Heath Market Drayton, GB Tf9 2eg |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-23 |
| Decision Date | 2021-08-19 |