IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL— 510(k) K971807
Substantially EquivalentHear-Right, Inc.
FDA 510(k) clearance K971807 for IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL, Substantially Equivalent on 1997-08-07. Applicant: Hear-Right, Inc.. Device class: 1.
Clearance details
- Applicant
- Hear-Right, Inc.
- Product code
- Code ESD
- Device class
- Class 1
- Regulation
- 21 CFR 874.3300
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oklahoma City, OK, US
Recent devices under product code ESD
view allData sourced from openFDA. This site is unofficial and independent of the FDA.