The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for Thermo-k.
| Device ID | K820814 |
| 510k Number | K820814 |
| Device Name: | THERMO-K |
| Classification | System, Thermal Regulating |
| Applicant | AMERICAN MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-24 |
| Decision Date | 1982-04-29 |