The following data is part of a premarket notification filed by Devon Medical Products with the FDA for Cirona 6400.
| Device ID | K161209 |
| 510k Number | K161209 |
| Device Name: | Cirona 6400 |
| Classification | Sleeve, Limb, Compressible |
| Applicant | DEVON MEDICAL PRODUCTS 1100 FIRST AVENUE King Of Prussia, PA 19119 |
| Contact | Rocco Bravoco |
| Correspondent | Rocco Bravoco DEVON MEDICAL PRODUCTS 1100 FIRST AVENUE King Of Prussia, PA 19119 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-28 |
| Decision Date | 2016-05-31 |