DOUBLE BALL JOINT— 510(k) K803166

Substantially Equivalent

Howmedica Corp.

FDA 510(k) clearance K803166 for DOUBLE BALL JOINT, Substantially Equivalent on 1981-01-09. Applicant: Howmedica Corp.. Device class: 2.

Clearance details

Applicant: Howmedica Corp.
Product code: Code JEC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1980-12-15
Decision date: 1981-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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