PARKE-DAVIS TOTAL KNEE PROSTHESIS— 510(k) K800363

Name: FDA 510(k) clearance K800363
Creator: U.S. Food and Drug Administration
Published: 1980-03-10

Substantially Equivalent

Warner-Lambert Co.

FDA 510(k) clearance K800363 for PARKE-DAVIS TOTAL KNEE PROSTHESIS, Substantially Equivalent on 1980-03-10. Applicant: Warner-Lambert Co.. Device class: 1.

Clearance details

Applicant: Warner-Lambert Co.
Product code: Code KTZ
Device class: Class 1
Regulation: 21 CFR 888.4150
Advisory panel: Orthopedic
Date received: 1980-02-20
Decision date: 1980-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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