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510(k) K894170

DEVON DISPOSABLE HEAD POSITIONER COVER by Devon Industries, Inc. — Product Code KME

K894170 is an FDA 510(k) premarket notification submitted by Devon Industries, Inc. for the device "DEVON DISPOSABLE HEAD POSITIONER COVER". The FDA issued a decision of Substantially Equivalent on September 7, 1989. The device falls under product code KME (Bedding, Disposable, Medical), a Class I device regulated under 21 CFR 880.6060. Devon Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1989
Date Received
June 15, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bedding, Disposable, Medical
Device Class
Class I
Regulation Number
880.6060
Review Panel
HO
Submission Type

Other clearances by Devon Industries, Inc.

  • K961993 — BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT) (July 3, 1996)
  • K954015 — ABG POINT LOK NEEDLE PROTECTION DEVICE (November 20, 1995)
  • K946289 — DEVONS POINT LOK NEEDLE PROTECTION DEVICE (July 10, 1995)
  • K944114 — PHLEBOTOMY UNIT SHARPS A GATOR (December 2, 1994)
  • K945197 — THE SHARPS COLLECTION AND DISPOSAL SYSTEM (December 2, 1994)
  • K943892 — POINT OF USE SHARPS A GATOR (December 2, 1994)
  • K945485 — ABG NEEDLE PROTECTION (November 29, 1994)
  • K932998 — EASY-ON (August 18, 1993)
  • K912824 — DEVON SPONGE COUNTER BAGS (August 26, 1991)
  • K892660 — HIBERNATION KIT (August 15, 1989)

Other clearances for product code KME

  • K042145 — READY-HEAT BLANKET (September 17, 2004)
  • K944953 — OREX MEDICAL BEDDING (December 2, 1994)
  • K933636 — DISPOSE-A-SHEET (January 26, 1994)
  • K932539 — DOCTOR DOWN --RESCUE WRAP (November 2, 1993)
  • K922143 — AMERICAN BURN SHEET (August 10, 1992)
  • K915303 — FOIL BABY BUNTING (February 20, 1992)
  • K912257 — CHEM-SLEEVE B (December 31, 1991)
  • K911953 — MEDI GUARD SHEETS/UNDERLAYS (May 28, 1991)
  • K911948 — MEDI GUARD PILLOWCASE (May 28, 1991)
  • K911952 — MEDI GUARD UNDERPAD (May 28, 1991)

FDA data resources