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510(k) K851853

STERILE GOWNS, MASKS & TOWELS by Biological & Environmental Control Laboratories

K851853 is an FDA 510(k) premarket notification submitted by Biological & Environmental Control Laboratories for the device "STERILE GOWNS, MASKS & TOWELS". The FDA issued a decision of Substantially Equivalent on May 16, 1985. Biological & Environmental Control Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1985
Date Received
April 26, 1985
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)
  • K863632 — UPDATED STERILE PROCEDURAL KIT (September 29, 1986)
  • K863637 — UPDATED STERILE GOWNS, MASKS AND TOWELS (September 29, 1986)

FDA data resources