SPLINTS(ALL TYPE)— 510(k) K852558

Substantially Equivalent

The Huxley Instrument Corp.

FDA 510(k) clearance K852558 for SPLINTS(ALL TYPE), Substantially Equivalent on 1985-07-02. Applicant: The Huxley Instrument Corp.. Device class: 1.

Clearance details

Applicant: The Huxley Instrument Corp.
Product code: Code FYH
Device class: Class 1
Regulation: 21 CFR 878.3910
Advisory panel: General, Plastic Surgery
Date received: 1985-06-17
Decision date: 1985-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Penn Yan, NY, US

Download summary PDF View on FDA.gov ↗

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