The following data is part of a premarket notification filed by Zewa Ag with the FDA for Therma-h.
| Device ID | K921189 |
| 510k Number | K921189 |
| Device Name: | THERMA-H |
| Classification | Device, Thermal, Hemorrhoids |
| Applicant | ZEWA AG 10438 NW 31ST TERRACE Miami, FL 33172 |
| Contact | Burk A Brandt |
| Correspondent | Burk A Brandt ZEWA AG 10438 NW 31ST TERRACE Miami, FL 33172 |
| Product Code | LKX |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-03 |
| Decision Date | 1992-08-31 |