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510(k) K896773

DISPOSABLE FACE MASK by Cadema Medical Products, Inc. — Product Code BYG

K896773 is an FDA 510(k) premarket notification submitted by Cadema Medical Products, Inc. for the device "DISPOSABLE FACE MASK". The FDA issued a decision of Substantially Equivalent on January 12, 1990. The device falls under product code BYG (Mask, Oxygen), a Class I device regulated under 21 CFR 868.5580. Cadema Medical Products, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1990
Date Received
December 1, 1989
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 Cadema Medical Products, Inc.

  • K901476 — MODIFIED ENTRAPPING FILTER (May 1, 1990)
  • K896116 — ENTRAPPING FILTER (November 17, 1989)
  • K881812 — AERO-MIST NEBULIZER (July 18, 1988)
  • K873930 — AEROSOL DELIVERY SYSTEM (AERO-TECH II) (December 7, 1987)
  • K800023 — LUNG AEROSOL UNIT (January 1, 1985)

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)
  • K940887 — SYSTEM 22 ADULT MASK (April 19, 1994)
  • K940888 — SYSTEM 22 PAEDIATRIC MASK (April 19, 1994)
  • K931952 — MEDWAY OXYGEN MASK (August 20, 1993)

FDA data resources