The following data is part of a premarket notification filed by Ethicare Products with the FDA for Nasal-throat Spray Irrigation Instrum..
| Device ID | K821481 |
| 510k Number | K821481 |
| Device Name: | NASAL-THROAT SPRAY IRRIGATION INSTRUM. |
| Classification | Stimulator, Caloric-water |
| Applicant | ETHICARE PRODUCTS 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 | 1982-05-18 |
| Decision Date | 1982-06-14 |