STERILE EQUIPMENT COVER— 510(k) K951214

Substantially Equivalent

Gulfstream Medical

FDA 510(k) clearance K951214 for STERILE EQUIPMENT COVER, Substantially Equivalent on 1995-05-16. Applicant: Gulfstream Medical. Device class: 2.

Clearance details

Applicant: Gulfstream Medical
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1995-03-17
Decision date: 1995-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Athens, TX, 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.