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510(k) K820451

INTRODUCER FOR ENDOTRACHEAL TUBE by Imed Corp. — Product Code BWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1982
Date Received
February 18, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Tube Introduction
Device Class
Class I
Regulation Number
868.5780
Review Panel
AN
Submission Type

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  • K951922 — ADMINISTRATION SETS WITH BALL FLOAT (July 19, 1995)
  • K950419 — THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS (June 21, 1995)
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  • K945070 — VERSASAE PLASTIC CANNULA- 11 GAUGE (January 13, 1995)
  • K931173 — PRIMARY ADMIN SET W/UNIV SP-MAN BELOW/ABV PUMP CH (April 15, 1994)
  • K933144 — GEMINI VOLUMETRIC INFUSION PUMP/CONTROLLER (October 12, 1993)
  • K924718 — SHROUDED NEEDLE DEVICES (June 18, 1993)

Other clearances for product code BWB

  • K884584 — TONGUE SEIZING FORCEPS WITH & WITHOUT RUBBER PADS (November 14, 1988)
  • K880318 — ROVENSTEIN FORCEPS (March 21, 1988)
  • K880319 — MAGILL FORCEPS (March 21, 1988)
  • K840313 — CAT. 9 ANESTHESIOLOGY RESPIRATORY DEV (February 4, 1984)
  • K834169 — OP-CON SURGICAL INSTRUMENT #9 (January 17, 1984)