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 |