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510(k) K863635

UPDATED STERILE ENDOTRACHEAL BRUSHES by Biological & Environmental Control Laboratories — Product Code EPE

K863635 is an FDA 510(k) premarket notification submitted by Biological & Environmental Control Laboratories for the device "UPDATED STERILE ENDOTRACHEAL BRUSHES". The FDA issued a decision of Substantially Equivalent on November 3, 1986. The device falls under product code EPE (Brush, Cleaning, Tracheal Tube), a Class I device regulated under 21 CFR 868.5795. Biological & Environmental Control Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1986
Date Received
September 17, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Brush, Cleaning, Tracheal Tube
Device Class
Class I
Regulation Number
868.5795
Review Panel
AN
Submission Type

Other clearances by Biological & Environmental Control Laboratories

  • K971500 — ACCESS SYSTEMS NEEDLELESS VIAL ADAPTER (August 18, 1997)
  • K962801 — SAFE MATE I.V. EXTENSION SETS (August 28, 1996)
  • K962802 — SAFE MATE I.V. FLUID DELIVERY SETS (August 28, 1996)
  • K961328 — BEC SHROUDED PLASTIC CANNULA (May 30, 1996)
  • K961327 — BEC NEEDLELESS INJECTION SITE (May 15, 1996)
  • K863633 — SAFETY PINS, ELASTIC BANDAGES & STOCKINETTES (October 16, 1986)
  • K863636 — UPDATED STERILE GENERAL HOSPITAL INSTRUMENTS (October 6, 1986)
  • K863632 — UPDATED STERILE PROCEDURAL KIT (September 29, 1986)
  • K863637 — UPDATED STERILE GOWNS, MASKS AND TOWELS (September 29, 1986)
  • K851851 — STERILE ENDOTRACHEAL BRUSHES (June 5, 1985)

Other clearances for product code EPE

  • K862563 — TRACHEOSTOMY CLEANSING SOLUTION (July 15, 1986)

FDA data resources