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510(k) K863606

BUTTERFLY NON-CORING NEEDLE SET by Cormed, Inc., Sub. C.R.Bard, Inc. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1986
Date Received
September 16, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by Cormed, Inc., Sub. C.R.Bard, Inc.

  • K860432 — PERCUTANEOUS INTRODUCER KIT (March 31, 1986)
  • K854019 — PORT-GARD (November 26, 1985)
  • K850967 — STERILE CORMED MEDIPORT (May 17, 1985)
  • K850674 — CORMED II AMBULATORY INFUSION PUMP (April 9, 1985)
  • K843083 — CORMED HUBER POINT NEEDLE (September 5, 1984)
  • K833915 — VASCULAR ACCESS CATH. REPAIR KIT (March 30, 1984)
  • K823553 — CORCATH H & B VASCULAR ACCESS CATHETER (January 5, 1983)

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