K-CAP-E, STERILE— 510(k) K914812

Substantially Equivalent

Westcon Orthopedics, Inc.

FDA 510(k) clearance K914812 for K-CAP-E, STERILE, Substantially Equivalent on 1992-01-09. Applicant: Westcon Orthopedics, Inc.. Device class: 2.

Clearance details

Applicant: Westcon Orthopedics, Inc.
Product code: Code LYT
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 1991-10-25
Decision date: 1992-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Three Bridges, NJ, US

Download summary PDF View on FDA.gov ↗

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