HYDROFERA SURGICAL SPEAR— 510(k) K974313

Substantially Equivalent

Hydrofera, LLC

FDA 510(k) clearance K974313 for HYDROFERA SURGICAL SPEAR, Substantially Equivalent on 1998-03-02. Applicant: Hydrofera, LLC. Device class: 2.

Clearance details

Applicant: Hydrofera, LLC
Product code: Code HOZ
Device class: Class 2
Regulation: 21 CFR 886.4790
Advisory panel: Ophthalmic
Date received: 1997-11-17
Decision date: 1998-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Willimantic, CT, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.