INCUS/STAPES PROSTHESIS— 510(k) K861369
Substantially EquivalentRichards Medical Co., Inc.
FDA 510(k) clearance K861369 for INCUS/STAPES PROSTHESIS, Substantially Equivalent on 1986-07-14. Applicant: Richards Medical Co., Inc.. Device class: 2.
Clearance details
- Applicant
- Richards Medical Co., Inc.
- Product code
- Code ETB
- Device class
- Class 2
- Regulation
- 21 CFR 874.3450
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Memphis, TN, US
Recent devices under product code ETB
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More clearances from Richards Medical Co., Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.