MARK I TOTAL KNEE SYS. ARTHROPLASTY— 510(k) K832302

Name: FDA 510(k) clearance K832302
Creator: U.S. Food and Drug Administration
Published: 1983-08-16

Substantially Equivalent

Advanced Biosearch Assn.

FDA 510(k) clearance K832302 for MARK I TOTAL KNEE SYS. ARTHROPLASTY, Substantially Equivalent on 1983-08-16. Applicant: Advanced Biosearch Assn.. Device class: 2.

Clearance details

Applicant: Advanced Biosearch Assn.
Product code: Code MBV
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 1983-07-14
Decision date: 1983-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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