The following data is part of a premarket notification filed by Polynovo Biomaterials Pty Ltd with the FDA for Novopore Dressing.
| Device ID | K132936 |
| 510k Number | K132936 |
| Device Name: | NOVOPORE DRESSING |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | POLYNOVO BIOMATERIALS PTY LTD 816 CONGRESS AVE. SUITE 1400 Austin, TX 78701 |
| Contact | Carrie Hetrick |
| Correspondent | Carrie Hetrick POLYNOVO BIOMATERIALS PTY LTD 816 CONGRESS AVE. SUITE 1400 Austin, TX 78701 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-18 |
| Decision Date | 2014-03-04 |
| Summary: | summary |