FDA Product Code
FDA Product Code HDW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.5350
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K140305 | CAYA CONTOURED DIAPHRAGM | Kessel Medintim GmbH | 2014-08-26 | Traditional | PDF ↗ |
| K080040 | ORTHO ALL-FLEX DIAPHRAGM | Johnson & Johnson Produtos Profissionais Ltda. | 2008-08-25 | Traditional | PDF ↗ |
| K063223 | MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS | CooperSurgical, Inc. | 2008-01-23 | Traditional | PDF ↗ |
| K800162 | ONCE TM | G.D. Searle and Co. | 1980-02-11 | Traditional | PDF ↗ |
Product code HDW · Class II · Obstetrics/Gynecology. Data: openFDA.