OREX MEDICAL BEDDING— 510(k) K944953

Substantially Equivalent

Thantex Specialties, Inc.

FDA 510(k) clearance K944953 for OREX MEDICAL BEDDING, Substantially Equivalent on 1994-12-02. Applicant: Thantex Specialties, Inc.. Device class: 1.

Clearance details

Applicant: Thantex Specialties, Inc.
Product code: Code KME
Device class: Class 1
Regulation: 21 CFR 880.6060
Advisory panel: General Hospital
Date received: 1994-10-07
Decision date: 1994-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Herndon, VA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KME

K042145 — READY-HEAT BLANKET2004-09-17
K933636 — DISPOSE-A-SHEET1994-01-26
K932539 — DOCTOR DOWN --RESCUE WRAP1993-11-02
K922143 — AMERICAN BURN SHEET1992-08-10
K915303 — FOIL BABY BUNTING1992-02-20

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.