DISPOSABLE FACE MASK— 510(k) K904719

Substantially Equivalent

Tri/Bor Medical, Inc.

FDA 510(k) clearance K904719 for DISPOSABLE FACE MASK, Substantially Equivalent on 1991-01-02. Applicant: Tri/Bor Medical, Inc.. Device class: 1.

Clearance details

Applicant: Tri/Bor Medical, Inc.
Product code: Code BYG
Device class: Class 1
Regulation: 21 CFR 868.5580
Advisory panel: Anesthesiology
Date received: 1990-10-18
Decision date: 1991-01-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westtown, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BYG

K963298 — FIRST AID KIT(S)1996-11-06
K962848 — HANS RUDOLPH NASAL CPAP MASK1996-10-16
K945482 — DISPOSABLE, CPAP OXYGEN MASK1995-09-19
K953464 — WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK1995-09-18
K953039 — VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS1995-09-15

More clearances from Tri/Bor Medical, Inc.

K904717 — MICRO-VENT NEBULIZER SYSTEM1991-04-01
K904718 — AERO-GEN NUBULIZER SYSTEM1991-04-01
K904715 — OXYGEN/AIR TUBING1991-01-02
K904716 — AERO-GEN NEBULIZER1991-01-02

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