The following data is part of a premarket notification filed by Devon Medical with the FDA for Extricare 100cc/ 250cc/ 400cc Canisters.
| Device ID | K132252 |
| 510k Number | K132252 |
| Device Name: | EXTRICARE 100CC/ 250CC/ 400CC CANISTERS |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | DEVON MEDICAL 1100 FIRST AVENUE SUITE 202 King Of Prussia, PA 19406 |
| Contact | Ruth Wu |
| Correspondent | Ruth Wu DEVON MEDICAL 1100 FIRST AVENUE SUITE 202 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 | 2013-07-19 |
| Decision Date | 2013-09-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20879766005505 | K132252 | 000 |
| 20879766005499 | K132252 | 000 |