The following data is part of a premarket notification filed by Kessel Medintim Gmbh with the FDA for Caya Contoured Diaphragm.
| Device ID | K140305 |
| 510k Number | K140305 |
| Device Name: | CAYA CONTOURED DIAPHRAGM |
| Classification | Diaphragm, Contraceptive (and Accessories) |
| Applicant | KESSEL MEDINTIM GMBH KELSTERBACHER STR. 28 MOERFELDEN WALLDORF Frankfurt, DE 64546 |
| Contact | Kessel Marketing |
| Correspondent | Kessel Marketing KESSEL MEDINTIM GMBH KELSTERBACHER STR. 28 MOERFELDEN WALLDORF Frankfurt, DE 64546 |
| Product Code | HDW |
| CFR Regulation Number | 884.5350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-07 |
| Decision Date | 2014-08-26 |
| Summary: | summary |