510(k) K800443
- Device
- HYGROTHERM
- Applicant
- JEDMED INSTRUMENT CO.
- 510(k) number
- K800443
- Product code
- ETP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-03-10
- Date received
- 1980-02-28
- Regulation
- 874.1800
- Classification name
- Stimulator, Caloric-water
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 8010573
- 3011310592
- 9710334
- 3005527904
- 9710051
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ETP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K863615 | ENTHERMO IRRIGATION UNIT | Jedmed Instrument Co. | 1986-12-16 |
| K820775 | VESTIBULARISET | Jedmed Instrument Co. | 1982-11-03 |
| K821481 | NASAL-THROAT SPRAY IRRIGATION INSTRUM. | Ethicare Products | 1982-06-14 |
| K813552 | MODEL 3000C CALORIC IRRIGATOR | Life-Tech Intl., Inc. | 1982-02-22 |
| K800442 | VARIOTHERM | Jedmed Instrument Co. | 1980-03-10 |
Legacy Summary#
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FDA Review#
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