The following data is part of a premarket notification filed by Clear Choice Therapeutics, Inc. with the FDA for Theia Npwt Foam Wound Dressing Kit.
| Device ID | K211277 |
| 510k Number | K211277 |
| Device Name: | Theia NPWT Foam Wound Dressing Kit |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | Clear Choice Therapeutics, Inc. 530 W Cloverhurst Ave. Athens, GA 30306 |
| Contact | Bret Batchelder |
| Correspondent | Kathy Herzog DuVal & Associates 1820 Medical Arts Building, 820 Nicollet Mall Minneapolis, MN 55402 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-27 |
| Decision Date | 2021-12-16 |