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510(k) K971500

ACCESS SYSTEMS NEEDLELESS VIAL ADAPTER by Biological & Environmental Control Laboratories — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1997
Date Received
April 24, 1997
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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  • 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)
  • K851851 — STERILE ENDOTRACHEAL BRUSHES (June 5, 1985)

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