OREX SURGICAL DRAPES— 510(k) K944859

Substantially Equivalent

Thantex Specialties, Inc.

FDA 510(k) clearance K944859 for OREX SURGICAL DRAPES, Substantially Equivalent on 1995-02-28. Applicant: Thantex Specialties, Inc.. Device class: 2.

Clearance details

Applicant: Thantex Specialties, Inc.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1994-10-03
Decision date: 1995-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Herndon, VA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Thantex Specialties, Inc.

K970547 — ISOLYSER SDS SHARPS CONTAINER1997-07-18
K961083 — OREX SURGEON'S VEST1996-08-23
K942200 — ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS1995-08-07
K943626 — ISOLYSER SHARPS MANAGEMENT SYSTEM SMS1995-06-16
K945755 — OREX(R) O.R EQUIPMENT DRAPES1995-05-25

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