The following data is part of a premarket notification filed by Lc Medical Concepts, Inc. with the FDA for Theia Npwt Foam Wound Dressing Kit-small, Theia Npwt Foam Wound Dressing Kit-medium, Theia Npwt Foam Wound Dressing Kit-large.
| Device ID | K161570 |
| 510k Number | K161570 |
| Device Name: | Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | LC Medical Concepts, Inc. PO Box 502 Penfield, NY 14526 |
| Contact | Dana M. Ledgerwood |
| Correspondent | Dana M. Ledgerwood LC Medical Concepts, Inc. PO Box 502 Penfield, NY 14526 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-07 |
| Decision Date | 2016-08-29 |
| Summary: | summary |