The following data is part of a premarket notification filed by Devon Medical Inc. with the FDA for Extricare Npwt Foot Dressing.
| Device ID | K131464 |
| 510k Number | K131464 |
| Device Name: | EXTRICARE NPWT FOOT DRESSING |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | DEVON MEDICAL INC. 1100 1ST AVENUE SUITE 200 King Of Prussia, PA 19406 |
| Contact | Ruth Wu |
| Correspondent | Ruth Wu DEVON MEDICAL INC. 1100 1ST AVENUE SUITE 200 King Of Prussia, PA 19406 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-21 |
| Decision Date | 2013-08-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20879766005635 | K131464 | 000 |