AUTO SUTURE SPINAL OSTEOTOME— 510(k) K942968

Name: FDA 510(k) clearance K942968
Creator: U.S. Food and Drug Administration
Published: 1994-07-20

Substantially Equivalent

United States Surgical, A Division of Tyco Healthc

FDA 510(k) clearance K942968 for AUTO SUTURE SPINAL OSTEOTOME, Substantially Equivalent on 1994-07-20. Applicant: United States Surgical, A Division of Tyco Healthc. Device class: 1.

Clearance details

Applicant: United States Surgical, A Division of Tyco Healthc
Product code: Code HAO
Device class: Class 1
Regulation: 21 CFR 882.4535
Advisory panel: Neurology
Date received: 1994-06-20
Decision date: 1994-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwalk, CT, US

Download summary PDF View on FDA.gov ↗

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