510(k) K823872
- Device
- EMERGENCY TRACHEOSTOMY KIT
- Applicant
- OMNICON MEDICAL CORP.
- 510(k) number
- K823872
- Product code
- EWC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-01-21
- Date received
- 1982-12-27
- Regulation
- 874.1060
- Classification name
- Chamber, Acoustic (for Audiometric Testing)
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 9610612
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EWC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K822269 | NAGASHIMA SN SOUND-PROOF CHAMBER-HEARING | Kelleher Corp. | 1982-09-09 |
Legacy Summary#
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FDA Review#
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