The following data is part of a premarket notification filed by Iasis Medical, Inc. with the FDA for Npd 1000 Negative Pressure Wound Therapy System.
| Device ID | K080275 |
| 510k Number | K080275 |
| Device Name: | NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | IASIS MEDICAL, INC. 6393 OAKGREEN AVENUE Hastings, MN 55033 |
| Contact | John Buan |
| Correspondent | John Buan IASIS MEDICAL, INC. 6393 OAKGREEN AVENUE Hastings, MN 55033 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-01 |
| Decision Date | 2008-10-09 |
| Summary: | summary |