The following data is part of a premarket notification filed by Devon Medical Inc. with the FDA for Extricare Npwt Foot Dressing.
Device ID | K131464 |
510k Number | K131464 |
Device Name: | EXTRICARE NPWT FOOT DRESSING |
Classification | Negative Pressure Wound Therapy Powered Suction Pump |
Applicant | DEVON MEDICAL INC. 1100 1ST AVENUE SUITE 200 King Of Prussia, PA 19406 |
Contact | Ruth Wu |
Correspondent | Ruth Wu DEVON MEDICAL INC. 1100 1ST AVENUE SUITE 200 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 | 2013-05-21 |
Decision Date | 2013-08-13 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20879766005635 | K131464 | 000 |