STERILE FIELD #605 FENESTRATED STERILE FIELD #606— 510(k) K864111

Name: FDA 510(k) clearance K864111
Creator: U.S. Food and Drug Administration
Published: 1986-10-30

Substantially Equivalent

Graham Medical Products

FDA 510(k) clearance K864111 for STERILE FIELD #605 FENESTRATED STERILE FIELD #606, Substantially Equivalent on 1986-10-30. Applicant: Graham Medical Products. Device class: 2.

Clearance details

Applicant: Graham Medical Products
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1986-10-21
Decision date: 1986-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Holyoke, MA, US

Download summary PDF View on FDA.gov ↗

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