The following data is part of a premarket notification filed by Cork Medical Products Llc with the FDA for Nisus Negative Pressure Wound Therapy Pump, Nisus Npwt Canister 250-ml, Nisus Npwt Canister 500-ml, Cork Medical Product.
| Device ID | K140022 |
| 510k Number | K140022 |
| Device Name: | NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS NPWT CANISTER 500-ML, CORK MEDICAL PRODUCT |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | CORK MEDICAL PRODUCTS LLC PO BOX 1784 Martinsville, IN 46151 |
| Contact | Jon Speer |
| Correspondent | Jon Speer CORK MEDICAL PRODUCTS LLC PO BOX 1784 Martinsville, IN 46151 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-03 |
| Decision Date | 2014-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851675007135 | K140022 | 000 |
| 00851675007104 | K140022 | 000 |
| 00851675007098 | K140022 | 000 |
| 00851675007005 | K140022 | 000 |