The following data is part of a premarket notification filed by Devon Medical Products with the FDA for Extricare 3600 Negative Pressure Wound Therapy System 1000cc Canister.
| Device ID | K143362 |
| 510k Number | K143362 |
| Device Name: | ExtriCARE 3600 Negative Pressure Wound Therapy System 1000cc Canister |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | Devon Medical Products 1100 First Avenue, Suite 202 King Of Prussia, PA 19406 |
| Contact | John Siegel |
| Correspondent | Rocco Bravoco Devon Medical Products 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 | 2014-11-24 |
| Decision Date | 2015-02-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14897089070047 | K143362 | 000 |