PRECISION HARVEST & INLAY INSTRUMENT SET— 510(k) K851339

Name: FDA 510(k) clearance K851339
Creator: U.S. Food and Drug Administration
Published: 1985-07-02

Substantially Equivalent

Concept, Inc.

FDA 510(k) clearance K851339 for PRECISION HARVEST & INLAY INSTRUMENT SET, Substantially Equivalent on 1985-07-02. Applicant: Concept, Inc.. Device class: 1.

Clearance details

Applicant: Concept, Inc.
Product code: Code HWK
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1985-04-03
Decision date: 1985-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

Download summary PDF View on FDA.gov ↗

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