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510(k) K831637

ACCU-FLUSH by Accu-Line — Product Code KRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1983
Date Received
May 23, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Continuous Flush
Device Class
Class II
Regulation Number
870.1210
Review Panel
CV
Submission Type

Other clearances by Accu-Line

  • K831847 — JEJUNOSTOMY KIT (August 31, 1983)
  • K831636 — PERCUTANEOUS INTRODUCER KIT (August 24, 1983)
  • K830298 — ACCU-LINE SURGICAL MARKER (June 2, 1983)

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