510(k) K823774
- Device
- WILSON EUSTACHIAN TUBAL, SONOGRAPH
- Applicant
- ANTARES TECHNICAL ASSOCIATES, INC.
- 510(k) number
- K823774
- Product code
- ETK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-01-17
- Date received
- 1982-12-14
- Regulation
- 874.1925
- Classification name
- Tube, Toynbee Diagnostic
- 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#
- 3013846070
- 8040278
- 3011137372
- 3008808049
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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