The following data is part of a premarket notification filed by Devon Medical Products with the FDA for Extricare Negative Pressure Wound Therapy Gel Strip - 8pc, Extricare Negative Pressure Wound Therapy Gel Strip - 7pc, Extricare Negative Pressure Wound Therapy Gel Strip - 6pc, Extricare Negative Pressure Wound Therapy Gel Strip - 5pc, Extricare Nega.
| Device ID | K151240 |
| 510k Number | K151240 |
| Device Name: | ExtriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, ExtriCARE Negative Pressure Wound Therapy Gel Strip - 7pc, ExtriCARE Negative Pressure Wound Therapy Gel Strip - 6pc, ExtriCARE Negative Pressure Wound Therapy Gel Strip - 5pc, ExtriCARE Nega |
| 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 | Steve Xu 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 | 2015-05-11 |
| Decision Date | 2015-06-09 |