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510(k) K940319

R-GROUP INTERNATIONAL COILED LOW PRESSURE EXTENSION LINE by R-Group Intl. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1994
Date Received
January 24, 1994
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

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  • K952470 — ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II. (November 28, 1995)
  • K954035 — ACTI-FLEX ARTERIAL EXTENSION SET (September 25, 1995)
  • K913267 — R-GROUP INTL. ONE WALL PUNCTURE NEEDLE (June 5, 1992)

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