510(k) K140305
- Device
- CAYA CONTOURED DIAPHRAGM
- Applicant
- KESSEL MEDINTIM GMBH
- 510(k) number
- K140305
- Product code
- HDW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-08-26
- Date received
- 2014-02-07
- Regulation
- 884.5350
- Classification name
- Diaphragm, Contraceptive (and Accessories)
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KESSEL MARKETING
- Address
- Kelsterbacher St. 28 Moerfelden Walldorf Frankfurt DE 64546 64546
FDA Registration Numbers#
- 1216677
- 3011014178
- 3013942365
Source Documents#
Other 510(k) Records For Product Code HDW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K080040 | ORTHO ALL-FLEX DIAPHRAGM | Johnson & Johnson Produtos Profissionais Ltda. | 2008-08-25 |
| K063223 | MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS | CooperSurgical, Inc. | 2008-01-23 |
| K800162 | ONCE TM | G.D. Searle and Co. | 1980-02-11 |
Legacy Summary#
summary
FDA Review#
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