Home / 510(k) Clearances / K904719

510(k) K904719

DISPOSABLE FACE MASK by Tri/Bor Medical, Inc. — Product Code BYG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 1991
Date Received
October 18, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Oxygen
Device Class
Class I
Regulation Number
868.5580
Review Panel
AN
Submission Type

Other clearances by Tri/Bor Medical, Inc.

  • K904718 — AERO-GEN NUBULIZER SYSTEM (April 1, 1991)
  • K904717 — MICRO-VENT NEBULIZER SYSTEM (April 1, 1991)
  • K904715 — OXYGEN/AIR TUBING (January 2, 1991)
  • K904716 — AERO-GEN NEBULIZER (January 2, 1991)

Other clearances for product code BYG

  • K963298 — FIRST AID KIT(S) (November 6, 1996)
  • K962848 — HANS RUDOLPH NASAL CPAP MASK (October 16, 1996)
  • K945482 — DISPOSABLE, CPAP OXYGEN MASK (September 19, 1995)
  • K953464 — WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK (September 18, 1995)
  • K953039 — VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS (September 15, 1995)
  • K945472 — WESTMED PEDIATRIC AND ADULT AEROSOL MASK (February 7, 1995)
  • K942907 — JEMSDAL MASK (August 31, 1994)
  • K940888 — SYSTEM 22 PAEDIATRIC MASK (April 19, 1994)
  • K940887 — SYSTEM 22 ADULT MASK (April 19, 1994)
  • K931952 — MEDWAY OXYGEN MASK (August 20, 1993)