DRUMTO STAPES PROSTHESIS— 510(k) K832540
Substantially EquivalentHumboldt Products
FDA 510(k) clearance K832540 for DRUMTO STAPES PROSTHESIS, Substantially Equivalent on 1984-01-03. Applicant: Humboldt Products. Device class: 2.
Clearance details
- Applicant
- Humboldt Products
- 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
- Walker, MI, US
Recent devices under product code ETB
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- K260720 — mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717) +9 more
- K241142 — mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis
- K241261 — mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit
- K130512 — NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS
More clearances from Humboldt Products
view allData sourced from openFDA. This site is unofficial and independent of the FDA.