The following data is part of a premarket notification filed by Devon Medical with the FDA for Devon Cirona 6200 Dvt.
| Device ID | K141578 |
| 510k Number | K141578 |
| Device Name: | DEVON CIRONA 6200 DVT |
| Classification | Sleeve, Limb, Compressible |
| Applicant | DEVON MEDICAL 1100 FIRST AVENUE SUITE 202 King Of Prussia, PA 19406 |
| Contact | Ruth Wu |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-06-13 |
| Decision Date | 2014-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10879766005430 | K141578 | 000 |
| 10879766005348 | K141578 | 000 |
| 10879766005331 | K141578 | 000 |
| 10879766005324 | K141578 | 000 |
| 10879766005317 | K141578 | 000 |
| 10879766005300 | K141578 | 000 |
| 10879766005294 | K141578 | 000 |
| 10879766005287 | K141578 | 000 |