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510(k) K962801

SAFE MATE I.V. EXTENSION SETS by Biological & Environmental Control Laboratories — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1996
Date Received
July 18, 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

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

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