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510(k) K952470

ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II. by R-Group Intl. — Product Code GCD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1995
Date Received
May 26, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Connector, Catheter
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

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  • K954035 — ACTI-FLEX ARTERIAL EXTENSION SET (September 25, 1995)
  • K940319 — R-GROUP INTERNATIONAL COILED LOW PRESSURE EXTENSION LINE (November 10, 1994)
  • K913267 — R-GROUP INTL. ONE WALL PUNCTURE NEEDLE (June 5, 1992)

Other clearances for product code GCD

  • K940198 — L-CATH CONNECTOR ASSEMBLY (December 15, 1994)
  • K863446 — ANGIOMED HIGH PRESSURE CONNECTORS (September 23, 1986)
  • K851196 — INCISION DRAIN (June 4, 1985)
  • K851921 — Y CONNECTOR (May 17, 1985)
  • K760382 — CONNECTORS (November 2, 1976)
  • K760524 — CATHETER CONNECTOR, ARGYLE TUBING (November 2, 1976)
  • K760203 — TUBE, STERILE NON-CONDUCTIVE CONNECTING (July 19, 1976)