The following data is part of a premarket notification filed by Ontex Bvba with the FDA for Ontex And Other Proprietary Names.
| Device ID | K122603 |
| 510k Number | K122603 |
| Device Name: | ONTEX AND OTHER PROPRIETARY NAMES |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | ONTEX BVBA 30 NECK ROAD Old Lyme, CT 06371 |
| Contact | Robert J Staab |
| Correspondent | Robert J Staab ONTEX BVBA 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 | 2012-08-27 |
| Decision Date | 2012-12-19 |
| Summary: | summary |