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510(k) K863632

UPDATED STERILE PROCEDURAL KIT by Biological & Environmental Control Laboratories

K863632 is an FDA 510(k) premarket notification submitted by Biological & Environmental Control Laboratories for the device "UPDATED STERILE PROCEDURAL KIT". The FDA issued a decision of Substantially Equivalent on September 29, 1986. Biological & Environmental Control Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1986
Date Received
September 17, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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)
  • K851851 — STERILE ENDOTRACHEAL BRUSHES (June 5, 1985)

FDA data resources