OREX— 510(k) K940716

Substantially Equivalent

Thantex Specialties, Inc.

FDA 510(k) clearance K940716 for OREX, Substantially Equivalent on 1994-12-19. Applicant: Thantex Specialties, Inc.. Device class: Unclassified.

Clearance details

Applicant: Thantex Specialties, Inc.
Product code: Code EFQ
Device class: Unclassified
Advisory panel: Unknown
Date received: 1994-02-18
Decision date: 1994-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EFQ

K991757 — NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE1999-08-12
K991215 — SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S1999-06-11
K990974 — VITOP DRESSING1999-06-09
K990584 — GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE1999-04-23
K984187 — CROSSTEX NON-WOVEN SPONGES1999-02-18

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.