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510(k) K913267

R-GROUP INTL. ONE WALL PUNCTURE NEEDLE by R-Group Intl. — Product Code DRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1992
Date Received
July 23, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Trocar
Device Class
Class II
Regulation Number
870.1390
Review Panel
CV
Submission Type

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  • K993777 — DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES (May 25, 2000)
  • K952470 — ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II. (November 28, 1995)
  • K954035 — ACTI-FLEX ARTERIAL EXTENSION SET (September 25, 1995)
  • K940319 — R-GROUP INTERNATIONAL COILED LOW PRESSURE EXTENSION LINE (November 10, 1994)

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  • K172893 — SafeSept Needle Free Transseptal Guidewire (December 21, 2017)
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