The following data is part of a premarket notification filed by Devon Medical Inc. with the FDA for Circuflow 5150.
| Device ID | K123959 |
| 510k Number | K123959 |
| Device Name: | CIRCUFLOW 5150 |
| Classification | Sleeve, Limb, Compressible |
| Applicant | DEVON MEDICAL INC. 1100 1ST AVENUE SUITE 100 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 | 2012-12-21 |
| Decision Date | 2013-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00879766005358 | K123959 | 000 |