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510(k) K771426

PEDIATRIC INFUSION T by Quinton, Inc. — Product Code FKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1977
Date Received
August 1, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Connector, Blood Tubing, Infusion T
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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  • K964784 — SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431) (August 13, 1997)
  • K964978 — VITAL STATISTICS SYSTEM (O-CATH ACCESSORY) (May 21, 1997)
  • K955002 — MAHURKAR 8 FR DUAL LEMEN CATHETER (September 13, 1996)

Other clearances for product code FKB

  • K891754 — DC-4 SHUNT INFUSION T (April 7, 1989)