The following data is part of a premarket notification filed by Kure Swiss Medical Ag Corp. with the FDA for Therma-h.
| Device ID | K905276 |
| 510k Number | K905276 |
| Device Name: | THERMA-H |
| Classification | Device, Thermal, Hemorrhoids |
| Applicant | KURE SWISS MEDICAL AG CORP. 501 BRICKELL KEY DR. Miami, FL 33131 |
| Contact | Edgar Hoffman |
| Correspondent | Edgar Hoffman KURE SWISS MEDICAL AG CORP. 501 BRICKELL KEY DR. Miami, FL 33131 |
| 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 | 1990-11-23 |
| Decision Date | 1991-11-07 |