The following data is part of a premarket notification filed by Devon Medical, Inc. with the FDA for Extricare 2400 Npwt System With Extricare 2400 Npwt Pump And Extricare Npwt Foam Dressing Kit.
| Device ID | K140634 |
| 510k Number | K140634 |
| Device Name: | ExtriCARE 2400 NPWT System With ExtriCARE 2400 NPWT Pump And ExtriCARE NPWT Foam Dressing Kit |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | Devon Medical, Inc. 1100 First Avenue, Suite 202 King Of Prussia, PA 19406 |
| Contact | Steve Xu |
| Correspondent | Steve Xu Devon Medical, Inc. 1100 First Avenue, Suite 202 King Of Prussia, PA 19406 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-12 |
| Decision Date | 2014-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14897089070412 | K140634 | 000 |
| 14897089070191 | K140634 | 000 |
| 14897089070153 | K140634 | 000 |
| 14897089070146 | K140634 | 000 |
| 14897089070054 | K140634 | 000 |
| 14897089070214 | K140634 | 000 |