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 |