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510(k) K961327

BEC NEEDLELESS INJECTION SITE by Biological & Environmental Control Laboratories — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1996
Date Received
April 8, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Biological & Environmental Control Laboratories

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  • K962801 — SAFE MATE I.V. EXTENSION SETS (August 28, 1996)
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  • K961328 — BEC SHROUDED PLASTIC CANNULA (May 30, 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)
  • K851851 — STERILE ENDOTRACHEAL BRUSHES (June 5, 1985)

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