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510(k) K850067

MEDICAL, DISPOSABLE BEDDING by East Texas Lighthouse For the Blind — Product Code KME

K850067 is an FDA 510(k) premarket notification submitted by East Texas Lighthouse For the Blind for the device "MEDICAL, DISPOSABLE BEDDING". The FDA issued a decision of Substantially Equivalent on April 19, 1985. The device falls under product code KME (Bedding, Disposable, Medical), a Class I device regulated under 21 CFR 880.6060. East Texas Lighthouse For the Blind has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1985
Date Received
January 8, 1985
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 East Texas Lighthouse For the Blind

  • K883376 — STERILIZATION WRAP TYPE 22,44,77 (September 28, 1988)
  • K882275 — STERILE PACK (PROCEDURAL TRAY/KITS) (July 18, 1988)
  • K863733 — TOWEL PACK, SURGICAL (October 14, 1986)
  • K862062 — NONWOVEN SURGICAL DRAPE PACK (June 10, 1986)
  • K850811 — PAD, PRE-OPERATIVE PREPARATION (March 21, 1985)
  • K850016 — TOWEL PACK, SURGICAL (January 23, 1985)

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