SILASTIC HEMI WRIST IMPLANT H.P. (RAD.)— 510(k) K812053

Name: FDA 510(k) clearance K812053
Creator: U.S. Food and Drug Administration
Published: 1981-08-18

Substantially Equivalent

Dow Corning Corp. Healthcare Industries Materials

FDA 510(k) clearance K812053 for SILASTIC HEMI WRIST IMPLANT H.P. (RAD.), Substantially Equivalent on 1981-08-18. Applicant: Dow Corning Corp. Healthcare Industries Materials. Device class: 2.

Clearance details

Applicant: Dow Corning Corp. Healthcare Industries Materials
Product code: Code KXE
Device class: Class 2
Regulation: 21 CFR 888.3810
Advisory panel: Orthopedic
Date received: 1981-07-21
Decision date: 1981-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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