SILASTIC HAMMERTOE IMPLANT (SWANSON-WELL— 510(k) K801094

Name: FDA 510(k) clearance K801094
Creator: U.S. Food and Drug Administration
Published: 1980-06-09

Substantially Equivalent

Dow Corning Corp. Healthcare Industries Materials

FDA 510(k) clearance K801094 for SILASTIC HAMMERTOE IMPLANT (SWANSON-WELL, Substantially Equivalent on 1980-06-09. Applicant: Dow Corning Corp. Healthcare Industries Materials. Device class: 2.

Clearance details

Applicant: Dow Corning Corp. Healthcare Industries Materials
Product code: Code KWH
Device class: Class 2
Regulation: 21 CFR 888.3720
Advisory panel: Orthopedic
Date received: 1980-05-08
Decision date: 1980-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K850255 — DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMET1985-05-01
K843995 — TF-II HIP PROSTHESIS1985-04-23
K842559 — WHITESIDE ORTHOLOC TOTAL HIP FEMORAL1984-12-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.