The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Model 3000c Caloric Irrigator.
| Device ID | K813552 |
| 510k Number | K813552 |
| Device Name: | MODEL 3000C CALORIC IRRIGATOR |
| Classification | Stimulator, Caloric-water |
| Applicant | LIFE-TECH INTL., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | ETP |
| CFR Regulation Number | 874.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-21 |
| Decision Date | 1982-02-22 |