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510(k) K844196

WET SKIN SCRUB TRAY STERILE WET SKIN SCRUB KIT by Biological & Environmental Control Laboratories — Product Code KME

K844196 is an FDA 510(k) premarket notification submitted by Biological & Environmental Control Laboratories for the device "WET SKIN SCRUB TRAY STERILE WET SKIN SCRUB KIT". The FDA issued a decision of Substantially Equivalent on December 4, 1984. The device falls under product code KME (Bedding, Disposable, Medical), a Class I device regulated under 21 CFR 880.6060. Biological & Environmental Control Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1984
Date Received
October 30, 1984
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 Biological & Environmental Control Laboratories

  • K971500 — ACCESS SYSTEMS NEEDLELESS VIAL ADAPTER (August 18, 1997)
  • K962802 — SAFE MATE I.V. FLUID DELIVERY SETS (August 28, 1996)
  • K962801 — SAFE MATE I.V. EXTENSION SETS (August 28, 1996)
  • K961328 — BEC SHROUDED PLASTIC CANNULA (May 30, 1996)
  • K961327 — BEC NEEDLELESS INJECTION SITE (May 15, 1996)
  • K863635 — UPDATED STERILE ENDOTRACHEAL BRUSHES (November 3, 1986)
  • K863633 — SAFETY PINS, ELASTIC BANDAGES & STOCKINETTES (October 16, 1986)
  • K863636 — UPDATED STERILE GENERAL HOSPITAL INSTRUMENTS (October 6, 1986)
  • K863637 — UPDATED STERILE GOWNS, MASKS AND TOWELS (September 29, 1986)
  • K863632 — UPDATED STERILE PROCEDURAL KIT (September 29, 1986)

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