The following data is part of a premarket notification filed by Bodywise (uk), Ltd. with the FDA for Natracaren Applicator Tampon.
| Device ID | K954942 |
| 510k Number | K954942 |
| Device Name: | NATRACAREN APPLICATOR TAMPON |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | BODYWISE (UK), LTD. 14 LOWER COURT RD. LOWER ALMONDSBURY Bristol, Avon, GB Bs32 4dx |
| Contact | S. P. Hewson |
| Correspondent | S. P. Hewson BODYWISE (UK), LTD. 14 LOWER COURT RD. LOWER ALMONDSBURY Bristol, Avon, GB Bs32 4dx |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-30 |
| Decision Date | 1996-01-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05019493090028 | K954942 | 000 |
| 05019493080029 | K954942 | 000 |