The following data is part of a premarket notification filed by Johnson & Johnson Produtos Profissionais Ltda. with the FDA for Ortho All-flex Diaphragm.
| Device ID | K080040 |
| 510k Number | K080040 |
| Device Name: | ORTHO ALL-FLEX DIAPHRAGM |
| Classification | Diaphragm, Contraceptive (and Accessories) |
| Applicant | JOHNSON & JOHNSON PRODUTOS PROFISSIONAIS LTDA. 220 RIVER ROAD Claremont, NH 03743 -5647 |
| Contact | William Greenrose |
| Correspondent | William Greenrose JOHNSON & JOHNSON PRODUTOS PROFISSIONAIS LTDA. 220 RIVER ROAD Claremont, NH 03743 -5647 |
| Product Code | HDW |
| CFR Regulation Number | 884.5350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-07 |
| Decision Date | 2008-08-25 |
| Summary: | summary |