ANDREWS REMOTE CHUCK DRILL— 510(k) K831043

Name: FDA 510(k) clearance K831043
Creator: U.S. Food and Drug Administration
Published: 1983-04-28

Substantially Equivalent

Orthopedic Systems, Inc.

FDA 510(k) clearance K831043 for ANDREWS REMOTE CHUCK DRILL, Substantially Equivalent on 1983-04-28. Applicant: Orthopedic Systems, Inc.. Device class: 1.

Clearance details

Applicant: Orthopedic Systems, Inc.
Product code: Code HXY
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1983-03-31
Decision date: 1983-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K880046 — HASTING FINGER FIXATOR INSTRUMENTS1988-02-16

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