ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS— 510(k) K942200

Name: FDA 510(k) clearance K942200
Creator: U.S. Food and Drug Administration
Published: 1995-08-07

Substantially Equivalent

Thantex Specialties, Inc.

FDA 510(k) clearance K942200 for ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS, Substantially Equivalent on 1995-08-07. Applicant: Thantex Specialties, Inc.. Device class: 1.

Clearance details

Applicant: Thantex Specialties, Inc.
Product code: Code LYU
Device class: Class 1
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1994-05-05
Decision date: 1995-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

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